25 registrations that name butyrate as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 25 registrations
Status
Phase
7US sites across 5 states
1
2 to 4
5 to 19
20 or more
All 25 registrations
RecruitingNCT04858412
Study of HMB-enriched Amino Acid Supplementation in Patients With Alcoholic Liver Disease and COVID-19
No phase
The Cleveland Clinic
About 48 people
Started Apr 1, 2021
In plain words A study of butyrate in people 21 and older, run by The Cleveland Clinic. It plans to enroll about 48 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 21 and older. Conditions: Alcoholic Liver Disease; COVID 19 Pneumonia.
Child Pugh score 5-8, serum creatinine <3, Model for End Stage Liver Disease score (MELD) <25
Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 <93% or on oxygen supplement
Age of 21 years or older
2 more inclusion criteria and the exclusion criteria are on the listing.
Patients with COVID-19 and comorbidities including alcohol associated liver disease (ALD) are at risk for severe illness and abrupt or sudden clinical deterioration with ventilatory failure. â-hydroxy â-methyl butyrate (HMB), a non-nitrogenous leucine metabolite with anabolic properties, increases muscle mass and contractile function and enhances immune function. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT07154511
Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
Phase 1 and 2
Prabesh Kanel
About 45 people
Started Nov 7, 2025
In plain words A Phase 1 and 2 study of butyrate in people 45 and older, run by Prabesh Kanel. It plans to enroll about 45 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 45 and older. Conditions: Parkinson Disease; Parkinson Disease Dementia.
Male or Female, age 45 years and over.
Diagnosis of PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (Hughes et al., 1992) AND evidence of mild cognitive impairment (Litvan et al., 2012) OR Diagnosis of PDD (Emre et al., 2007).
If taking cholinesterase inhibitors, benzodiazepines, memantine, or anti-psychotic medications, on a stable regimen as defined by no medication changes for these drugs in prior 4 weeks.
The exclusion criteria are on the listing.
What it tests, as registered
Tributyrin; Placebo
Registered summary
The goal of this clinical trial is to learn if taking a tributyrin supplement works to improve memory and thinking and walking and balance in adults with Parkinson disease Parkinson disease dementia. It will also learn about the safety of tributyrin supplementation. The main questions it aims to answer are: 1. Does tributyrin improve memory/thinking test scores and walking/balance ability? 2. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT05877846
Precision Medicine and Physical Function
No phase
University of North Carolina, Chapel Hill
About 25 people
Started Nov 1, 2023
In plain words A study of butyrate in people 65 to 85, run by University of North Carolina, Chapel Hill. It plans to enroll about 25 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 65 to 85. Conditions: Frailty; Weakness, Muscle; Multiple Chronic Conditions.
English-speaking older adults aged 65 to 85 years (of all genders and sexes, race or ethnicity)
A University of North Carolina at Chapel Hill (UNC) Geriatrics Medicine clinic patient;
Chronic medical conditions -these are based on the 21 Medicare multiple chronic conditions (e.g., alcohol abuse, arthritis (osteoarthritis, rheumatoid), asthma, atrial fibrillation, autism spectrum disorders, cancer (breast, colorectal,…
The exclusion criteria are on the listing.
What it tests, as registered
Beta-hydroxymethyl butyrate supplement; Vitamin D supplement; Matching Beta-hydroxymethyl butyrate supplement without Vitamin D
Registered summary
The investigators aim to conduct a 12-week, single-arm, pre/post-intervention of b-hydroxy-methylbutyrate in persons aged 65 to 85 years to assess feasibility and acceptability of the intervention and study procedures, secondary outcomes of physical function and changes in multi-omics patterns, and exploratory outcomes that will allow the team to describe physical function phenotype. The investigators' primary outcomes are the: feasibility of the study procedures (including safety), feasibility of the intervention delivery, and acceptability of study procedures and measures. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT05166499
HMB Enriched Amino Acids to Reverse Muscle Loss in Cirrhosis
No phase
The Cleveland Clinic
About 24 people
Started Nov 30, 2021
In plain words A study of butyrate in people 21 to 65, run by The Cleveland Clinic. It plans to enroll about 24 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 21 to 65. Conditions: Cirrhosis, Liver.
Diagnosis of cirrhosis of the liver
Child-Pugh score of 5-8
The exclusion criteria are on the listing.
What it tests, as registered
Hydroxy Methyl Butyrate; Balanced Amino Acids
Registered summary
Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible complication in cirrhosis that increases morbidity and mortality before, during and after liver transplantation. No proven treatments exist for the prevention or reversal of sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT06653426
The NaBu Effect on Menstruation in Women
No phase
Magdy Milad, MD
About 15 people
Started Oct 1, 2024
In plain words A study of butyrate in female participants 18 and older, run by Magdy Milad, MD. It plans to enroll about 15 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 and older. Conditions: Menstrual Symptoms.
18 years or older.
Menstruating regularly or irregularly
Experiencing menstrual symptoms with an average baseline symptom score of at least 3 on a scale of 0 to 10 for at least one symptom during the initial pre-study rating period.
The exclusion criteria are on the listing.
What it tests, as registered
Sodium Butyrate (NaBu)
Registered summary
The purpose of this study is to evaluate the effect of once-daily Sodium butyrate (NaBu) on menstrual symptoms in women. The investigators posit that the use of NaBu will reduce menstrual symptoms after taking NaBu for 12 weeks.
Where, as registered
1 US site in 1 state.
RecruitingNCT07863180
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Phase 1 and 2
Prabesh Kanel
About 15 people
Starts Sep 2026 (estimated)
In plain words A Phase 1 and 2 study of butyrate in people 45 and older, run by Prabesh Kanel. It plans to enroll about 15 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 45 and older. Conditions: Parkinson Disease; Multiple System Atrophy; Progressive Supranuclear Palsy(PSP).
Male or Female, age 45 years and over.
Diagnosis of PSP-Richardson syndrome (RS) based on Movement Disorder Society (MDS) Criteria, including
Vertical supranuclear gaze palsy.
Repeated unprovoked falls OR tendency to fall on the pull test within 3 years.
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Tributyrin; Placebo
Registered summary
This research is studying a supplement called tributyrin in people with Progressive Supranuclear Palsy (PSP) to learn about its safety and tolerability as a potential treatment. The goal of this research study is to see if a similar supplementation regimen and virtual testing is feasible for people with PSP.
Where, as registered
1 US site in 1 state.
RecruitingNCT05218850
The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
Phase 2
Children's Hospital Los Angeles
About 10 people
Started Jun 29, 2022
In plain words A Phase 2 study of butyrate in people 7 to 21, run by Children's Hospital Los Angeles. It plans to enroll about 10 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 7 to 21. Conditions: Ulcerative Colitis.
7-21 years, mild to moderate ulcerative colitis
The exclusion criteria are on the listing.
What it tests, as registered
Butyrate
Registered summary
Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.
Where, as registered
1 US site in 1 state.
RecruitingNCT07404085
Epigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations
No phase
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
About 160 people
Started Nov 14, 2025
In plain words A study of butyrate in people 35 to 75, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital. It plans to enroll about 160 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 35 to 75. Conditions: Bipolar Disorder (BD); Depression - Major Depressive Disorder; Cognitive Impairment; Schizophrenia Disorders.
Confirmed ICD-10 diagnosis of BD or recurrent UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14) or SSD assessed relatively stable by primary clinician at time of inclusion.
Subjective cognitive complaints (self-reported: COBRA ≥12) or objectively-verified cognitive impairment (measured using Screening for Cognitive Impairment in Psychiatry SCIP: total score or at least two subscores ≥ 0.5 SD below expected…
The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood (depression or bipolar disorder; MD) or schizophrenia spectrum disorders. The investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs. The full summary is on the listing.
Where, as registered
No US site; Denmark (1).
RecruitingNCT06514573
Butyrate Supplementation in Children With Autism Spectrum Disorder (ASD) and Functional Gastrointestinal Disorders
No phase
Istituto Superiore di Sanità
About 128 people
Starts May 2025 (estimated)
In plain words A study of butyrate in people 3 to 6, run by Istituto Superiore di Sanità. It plans to enroll about 128 people at 3 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 3 to 6. Conditions: Autism Spectrum Disorder (ASD).
children aged 3-6 years
both sexes
ASD diagnosis and presence of FGIDs (6-item Gastrointestinal Severity Index (6-GSI) >7 from > 3 months)
The exclusion criteria are on the listing.
What it tests, as registered
Sodium Butyrate; Placebo (cornstarch)
Registered summary
Autism spectrum disorder (ASD) is a neurodevelopmental condition occurring in 1:77 Italian children. Several comorbidities are reported, including functional gastrointestinal disorders (FGIDs) present in up to 70% of patients. FGIDs are disorders resulting from a combination of symptoms affecting motility, hypersensitivity, and other functions, which are not caused by anatomic or organic origin and that impact the severity of ASD core symptoms and complicate the clinical management of ASD children, especially those who are non-verbal. The full summary is on the listing.
Where, as registered
No US site; Italy (3).
RecruitingNCT06147635
Prophylactic Tributyrin Supplementation in Acute Pancreatitis
Phase 2
St. Antonius Hospital
About 92 people
Started Feb 12, 2024
In plain words A Phase 2 study of butyrate in people 18 and older, run by St. Antonius Hospital. It plans to enroll about 92 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Acute Pancreatitis.
First episode of acute pancreatitis (AP)
Able to read and/or understand the study procedures
Able to give informed consent (or their legal representatives)
<24 hours after diagnosis of AP
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Micro-encapsulated granules of tributyrin (intervention); Micro-encapsulated granules of sunflower oil (placebo)
Registered summary
The goal of this clinical trial is to investigate the possible effects of tributyrin supplementation in patients with a first episode of acute pancreatitis. The main question it aims to answer is: • The effect of oral tributyrin supplementation on the plasma endotoxin level Participants will be randomized between two groups: intervention and control group. They will receive: \- three times daily 4grams of micro-encapsulated granules of tributyrin, and the control group three times daily 4 grams of micro-encapsulated sunflower oil (i.e. The full summary is on the listing.
Where, as registered
No US site; Netherlands (2).
RecruitingNCT06384313
Butyrate-enriched Triglyceride and Diabetes Prevention
No phase
Maastricht University Medical Center
About 48 people
Started Sep 19, 2024
In plain words A study of butyrate in people 20 to 70, run by Maastricht University Medical Center. It plans to enroll about 48 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 20 to 70; healthy volunteers accepted. Conditions: Type 2 Diabetes; PreDiabetes; Obesity.
5 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
butyrate/hexanoate-enriched triglycerides
Registered summary
A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. The full summary is on the listing.
Where, as registered
No US site; Netherlands (1).
RecruitingNCT07591012
Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease
No phase
University of Padova
About 40 people
Starts May 1, 2026 (estimated)
In plain words A study of butyrate in people 18 to 75, run by University of Padova. It plans to enroll about 40 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Ulcerative Colitis (Disorder).
Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence.
Age between 18 and 75 years old
Ability of subject to participate fully in all aspects of this clinical trial.
The exclusion criteria are on the listing.
What it tests, as registered
Butyrate
Registered summary
The goal of this clinical trial is to learn if a dietary supplement called ButyMixx can help people with ulcerative colitis in remission feel better and keep their intestines less inflamed. ButyMixx contains: * Sodium butyrate, a substance normally produced by our gut microbiota that helps protect the intestinal lining and reduce inflammation. * A "beneficial" yeast (Kluyveromyces marxianus), similar to probiotics, which may support the balance of the intestinal microbiota. It will also learn about the safety of dietary supplement. The full summary is on the listing.
Where, as registered
No US site; Italy (1).
RecruitingNCT06776016
Dietary Supplements to Treat Radiation-Induced Rectal Injury
Phase 2
Sixth Affiliated Hospital, Sun Yat-sen University
About 33 people
Started Jan 15, 2025
In plain words A Phase 2 study of butyrate in people 18 to 75, run by Sixth Affiliated Hospital, Sun Yat-sen University. It plans to enroll about 33 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Radiotherapy; Radiation Proctitis.
Age 18-75 years
At least 3 months since the completion of pelvic radiotherapy
No evidence of tumor recurrence or metastasis
Rectal bleeding with grade 1-2 by LENT-SOMA scales
The exclusion criteria are on the listing.
What it tests, as registered
Butyrate
Registered summary
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI). We hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. The study will test whether the supplements can lower the LENT-SOMA scales of rectal bleeding and enhance overall patient health. The full summary is on the listing.
Where, as registered
No US site; China (1).
RecruitingNCT07802002
A Prospective, Single-Arm Clinical Study of a Dietary Supplement for the Prevention of Acute Radiation-Induced Rectal Injury During Neoadjuvant Chemoradiotherapy for Rectal Cancer
No phase
Sixth Affiliated Hospital, Sun Yat-sen University
About 23 people
Started Jul 1, 2026
In plain words A study of butyrate in people 18 to 75, run by Sixth Affiliated Hospital, Sun Yat-sen University. It plans to enroll about 23 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Radiotherapy; Radiation-Induced Complications.
Histologically confirmed rectal adenocarcinoma.
Clinically staged as locally advanced rectal cancer (cT3-4 and/or N+). Planned to receive short-course radiotherapy or long-course radiotherapy combined with concurrent fluoropyrimidine-based chemotherapy.
ECOG performance status of 0 or 1.
Baseline defecation frequency < 3 times/day, with no significant abdominal pain or tenesmus.
The exclusion criteria are on the listing.
What it tests, as registered
Tributyrin
Registered summary
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as a dietary supplement for preventing acute radiation-induced rectal injury (ARII). Approximately 23 participants with locally advanced rectal cancer will receive tributyrin in addition to standard neoadjuvant chemoradiotherapy. We hypothesize that tributyrin will reduce the incidence of grade 2 or higher ARII, graded according to the RTOG/EORTC criteria. The full summary is on the listing.
Where, as registered
No US site; China (1).
RecruitingNCT07463495
The Metabolic Effects of Oral Tributyrin Administration
No phase
University of Aarhus
About 12 people
Started Feb 20, 2026
In plain words A study of butyrate in people 18 and older, run by University of Aarhus. It plans to enroll about 12 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Healthy Overweight/Obese.
A body mass index (BMI) between 30-45 kg/m2
Older than 18 years of age
HbA1c < 48 mmol/mol
Hemoglobin within normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
tributyrin; Control
Registered summary
The goal of this double-blinded randomized clinical cross-over trial is to investigate the metabolic and appetite regulating effects of oral tributyrin (a butyrate pro-drug) administration vs placebo. The main questions it aims to answer are: * Does tributyrin have glucose lowering properties in humans? * Does tributyrin reduce appetite in humans? A sample size calculation estimated a minimum of 10 participants. We expect to include 12 participants in this study. Tributyrin or placebo is ingested once or twice daily for 2x2 weeks, separated by a washout period of minimum 2 weeks. The full summary is on the listing.
Where, as registered
No US site; Denmark (1).
RecruitingNCT07183488
Metabolic Effects of Short-Chain Fatty Acids in Healthy Individuals
No phase
University of Copenhagen
About 10 people
Started Sep 10, 2025
In plain words A study of butyrate in people 18 to 40, run by University of Copenhagen. It plans to enroll about 10 people at 1 site, none in the US.
Propionate followed by Butyrate; Butyrate followed by Propionate; Propionate followed by Butyrate; Butyrate followed by Propionate
Registered summary
The primary objective of this study is to investigate the acute physiological and metabolic effects of ingesting the short-chain fatty acids (SCFA)s propionate (three carbon atoms long; C3:0) and butyrate (C4:0) in healthy men and women. This aim will be addressed through a block-randomized cross-over study including two visits with acute intake of propionate and butyrate, respectively. The hypothesis is that plasma ketone body levels will increase during the first three hours after intake of butyrate, but not propionate, in healthy individuals in the overnight fasted state.
Where, as registered
No US site; Denmark (1).
Not yet recruitingNCT07144033
Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
No phase
Chinese University of Hong Kong
About 216 people
Starts Jan 1, 2026 (estimated)
In plain words A study of butyrate in people 18 and older, run by Chinese University of Hong Kong. It plans to enroll about 216 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Pain, Acute; Pain, Chronic; Chronic Post Operative Pain.
Adult patients aged 18 or older
elective surgery
coronary artery bypass graft (CABG), valve repair/replacement, combined CABG/valve procedure, or major aortic procedure via sternotomy
The exclusion criteria are on the listing.
What it tests, as registered
Butyrate and Taurine; Placebo
Registered summary
This study is a single-center, phase II, randomized, placebo-controlled, Bayesian-designed, double-blinded trial Goal and Questions: The primary goal is to evaluate if a combination of taurine and butyrate can reduce chronic postsurgical pain (CPSP) in adult cardiac surgical patients. The study also aims to determine if these compounds are safe, effective in perioperative pain control, and feasible for improving postoperative outcomes. The full summary is on the listing.
Where, as registered
No US site; Hong Kong (1).
Not yet recruitingNCT07684248
Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease
No phase
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About 200 people
Starts Sep 15, 2026 (estimated)
In plain words A study of butyrate in people 18 to 75, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. It plans to enroll about 200 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Type 1 Diabetes.
Age 18-75 years.
Type 1 diabetes.
MASLD: Defined by a Controlled Attenuation Parameter (CAP) measured by Fibroscan® ≥248 dB/m (40).
Signed informed consent.
The exclusion criteria are on the listing.
What it tests, as registered
Intensive lifestyle modification (hypocaloric Mediterranean diet and promotion of physical activity); Butyrate; Intensive lifestyle modification + butyrate
Registered summary
Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is highly prevalent in individuals with type 1 diabetes (T1D) and is associated with increased cardiovascular and metabolic risk. However, evidence regarding effective therapeutic strategies for MASLD in T1D remains scarce. Lifestyle modification has shown benefits in obesity and type 2 diabetes, whereas butyrate, a microbiota-derived short-chain fatty acid, has emerged as a potential therapeutic approach because of its anti-inflammatory and metabolic effects. The full summary is on the listing.
Where, as registered
No US site; Spain (1).
Not yet recruitingNCT06797817
Tributyrin Treatment in Mild Alzheimer Disease: Assessment of Butyrate Effects Via the Gut-Brain
Phase 3
Universidad de Almeria
About 156 people
Starts Jun 1, 2026 (estimated)
In plain words A Phase 3 study of butyrate in people 18 and older, run by Universidad de Almeria. It plans to enroll about 156 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Alzheimer Disease (AD).
individuals diagnosed with mild AD within the past year (ICD-10: F00.1).
voluntary consent to participate in the study in accordance with the Declaration of Helsinki.
not currently enrolled in any other clinical trial that could confound the results.
The exclusion criteria are on the listing.
What it tests, as registered
tributyrin; Placebo
Registered summary
The goal of this clinical trial is to learn if tributyrin can help prevent or mitigate cognitive decline in individuals with mild Alzheimer's disease (AD). The trial will also examine the safety and effects of tributyrin on inflammation and gut microbiota. The main questions it aims to answer are: Does tributyrin reduce inflammation and neurodegeneration markers? How does tributyrin affect gut microbiota and intestinal permeability? Researchers will compare tributyrin to a placebo (a look-alike substance that contains no active ingredient) to evaluate its effectiveness. The full summary is on the listing.
Where, as registered
No US site; Spain (1).
Not yet recruitingNCT07025980
Effect of Sinbiotic With Multispecies Probiotics on Liver Parameters Liver Enzymes, Ultrasound, Elastography and Adipokines in Same Cases) in Patients With Metabolic Associated Steatotic Liver Disease.
Phase 2
Eva Cubric
About 114 people
Starts Jul 1, 2025 (estimated)
In plain words A Phase 2 study of butyrate in people 18 to 75, run by Eva Cubric. It plans to enroll about 114 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis); Diabetes Mellitus; Hypertension; Hyperlipidaemia.
MASLD confirmed by ultrasound and elastography with CAP > 260 dB/m/MHz;
other causes of chronic liver disease excluded and/or diagnosis confirmed by liver biopsy,
presence of metabolic syndrome according to the definition of the International Diabetes Federation (IDF): waist circumference for women over 80 cm or over 94 cm for men, and at least two of the other criteria (treated hypertensive or…
signed informed consent.
The exclusion criteria are on the listing.
What it tests, as registered
The test product is a ready-to-use sinbiotic preparation of multispecies probiotics, ca-butyrate and FOS; Placebo Drug
Registered summary
Scientific hypothesis: the use of a synbiotic preparation with a multi-strain probiotic in patients with MASLD can lead to a decrease in non-invasive elastographic parameters of hepatic steatosis and fibrosis and an improvement in liver function. The main objective of this study is to examine whether the test product affects the improvement of liver function measured by elastographic parameters or at least the prevention of further disease progression. The full summary is on the listing.
Where, as registered
No US site; Croatia (1).
Not yet recruitingNCT07503548
Effect of Tributyrin Supplementation on Glycemic Control, Inflammation, and Cardiovascular Risk in Patients With Type 2 Diabetes
Phase 3
Ain Shams University
About 60 people
Starts Mar 26, 2026 (estimated)
In plain words A Phase 3 study of butyrate in people 18 to 70, run by Ain Shams University. It plans to enroll about 60 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 70. Conditions: Diabete Mellitus.
• Diagnosed with Type 2 DM for ≥ 1 year
ASCVD 10-year risk ≥ 7.5%
Stable antidiabetic and cardiovascular medication regimen for ≥ 3 months
Able to provide informed consent and comply with study procedures
The exclusion criteria are on the listing.
What it tests, as registered
tributyrin; Placebo
Registered summary
This study evaluates the effectiveness and safety of tributyrin supplementation in patients with type 2 diabetes mellitus (T2DM) who are at increased risk of cardiovascular disease. Type 2 diabetes is commonly associated with poor blood sugar control, chronic inflammation, oxidative stress, and an increased risk of heart disease. Tributyrin is a dietary supplement that acts as a precursor to butyrate, a compound known for its anti-inflammatory and metabolic benefits. It may help improve blood sugar levels, reduce inflammation, and lower cardiovascular risk. The full summary is on the listing.
Where, as registered
No US site; Egypt (1).
Not yet recruitingNCT03660176
Effects of Butyrate Enemas on Postoperative Intestinal Motility Disorders in Hirschsprung's Disease
Phase 3
Assistance Publique Hopitaux De Marseille
About 58 people
Starts Nov 2026 (estimated)
In plain words A Phase 3 study of butyrate in people 7 days to 17, run by Assistance Publique Hopitaux De Marseille. It plans to enroll about 58 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 7 days to 17. Conditions: Hirschsprung's Disease.
Newborn with a diagnosis of Hirschsprung's disease the 2 first months of life managed successfully with colonic decompressions/irrigations before curative surgery (usually performed 1-3 times a day)
Born at or after 35 weeks of gestation (37 weeks of amenorrhea)
With a short-segment Hirschsprung's disease limited to the rectum and/or sigmoid colon diagnosed on rectal biopsy with established pathological criteria (absence of ganglionic cells +/- hypertrophic extrinsic nerve fibres) (Kapur, 2009)
Uncomplicated form (without enterocolitis as defined by the HAEC score and/or diverting colostomy)
28 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Sodium Butyrate; routine management
Registered summary
Hirschsprung's disease (HD) is a rare congenital disorder (1/5000) defined by the absence of ganglion cells in the submucosal and myenteric plexuses along a variable length of the digestive tract. This abnormality most often leads to distal bowel obstruction in newborns with delayed passage of meconium. Treatment is surgical and consists in the resection of the aganglionic and transitional segments. However, the postoperative outcomes remain unpredictable. The full summary is on the listing.
Where, as registered
No US site; France (1).
Not yet recruitingNCT07583017
Effect of Oral Calcium Butyrate Supplementation in Obesity
No phase
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About 42 people
Starts Aug 1, 2026 (estimated)
In plain words A study of butyrate in people 18 and older, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. It plans to enroll about 42 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Obesity.
Signing of the informed consent form.
Adults aged ≥18 years of age.
Body mass index (BMI) >30 kg/m².
Both sex
The exclusion criteria are on the listing.
What it tests, as registered
Placebo; Calcium butyrate
Registered summary
Obesity is characterized by gut microbiota dysbiosis, in which beneficial metabolites such as butyrate are reduced. Butyrate is a short-chain fatty acid produced by microbial fermentation that plays a key role in maintaining intestinal barrier integrity, regulating immune responses, and supporting mitochondrial function. Its depletion contributes to disruption of the intestinal barrier, facilitating the translocation of bacterial components and promoting systemic inflammation mediated by immune cell activation, like monocytes. The full summary is on the listing.
Where, as registered
No US site; Mexico (1).
Not yet recruitingNCT07723729
Butyrate Yogurt for Cancer Constipation
Phase 2
Tianjin Medical University Cancer Institute and Hospital
About 30 people
Starts Aug 1, 2026 (estimated)
In plain words A Phase 2 study of butyrate in people 18 and older, run by Tianjin Medical University Cancer Institute and Hospital. It plans to enroll about 30 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Constipation; Gastrointestinal Cancer.
Age ≥ 18 years.
Histologically confirmed diagnosis of gastrointestinal malignancy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Confirmed < 3 spontaneous bowel movements (CSBM) per week during the 1-week baseline period, accompanied by constipation-related symptoms (e.g., straining, hard/lumpy stools, sensation of incomplete evacuation, etc.).
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
butyrate-containing short-chain fatty acid yogurt
Registered summary
Constipation is a common yet underrecognized supportive care issue in cancer patients. Its consequences extend beyond physical discomfort to include impaired quality of life, reduced opioid adherence leading to inadequate analgesia, and increased risks of fecal impaction, emergency visits, and hospitalization. The full summary is on the listing.
Where, as registered
No sites listed yet.
Not yet recruitingNCT07004257
ButOx Human Trial: An Open Label Prospective Cohort Study to Investigate the Effect of Tributyrin (Butyrate Precursor Molecule) Supplementation on Markers of Calcium Oxalate Nephrolithiasis
No phase
University of British Columbia
About 10 people
Starts Jul 1, 2025 (estimated)
In plain words A study of butyrate in people 19 and older, run by University of British Columbia. It plans to enroll about 10 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 19 and older; healthy volunteers accepted. Conditions: Urolithiasis.
Age ≥ 19 years.
History of nephrolithiasis, diagnosed with a kidney stone containing >80% calcium (from stone analysis of spontaneously passed or surgically removed kidney stone) within the past 3 years
Written informed consent
The exclusion criteria are on the listing.
What it tests, as registered
tributyrin
Registered summary
Kidney stone disease (KSD) is a condition where there are crystal deposits in the kidney. The gut microbiome is a community of gut bacteria which can produce substances such as short chain fatty acids (SCFAs). Individuals with KSD have a different gut microbiome composition and lower amounts of these SCFAs compared to healthy individuals. Tributyrin is a supplement which can increase levels of SCFAs. Our data from animal studies indicate that tributyrin supplementation may be able to reduce kidney stone formation. The full summary is on the listing.