Clostridium butyricum trials recruiting now

10 registrations that name clostridium butyricum 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 10 registrations

Status

Phase

44US sites across 9 states

All 10 registrations

RecruitingNCT07383441

Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

  • Phase 3
  • SWOG Cancer Research Network
  • About 718 people
  • Started Jun 5, 2026

In plain words A Phase 3 study of clostridium butyricum in people 18 and older, run by SWOG Cancer Research Network. It plans to enroll about 718 people at 41 US sites.

Who it lists and where

Who the trial lists, as registered

Lists people 18 and older. Conditions: Advanced Clear Cell Renal Cell Carcinoma; Metastatic Clear Cell Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8.

  • Participants must have histologically confirmed renal cell carcinoma (RCC) with clear cell component that is advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC at the time of registration on study
  • Participants must have measurable/evaluable disease by RECIST 1.1 criteria. Participants with only bone metastases or only pleural effusions are considered evaluable disease and are eligible
  • Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated treatment…
  • Participants must not be currently enrolled or plan to participate in treatment studies while enrolled on this study

34 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Axitinib; Biospecimen Collection; Bone Scan; Cabozantinib; Clostridium butyricum CBM 588 Probiotic Strain; Computed Tomography; Ipilimumab; Lenvatinib; Magnetic Resonance Imaging; Nivolumab; Nivolumab and Recombinant Human Hyaluronidase; Pembrolizumab; Placebo Administration

Registered summary

This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). The full summary is on the listing.

Where, as registered

41 US sites in 8 states.

RecruitingNCT07037004

Adding a Live Biotherapeutic Product (CBM588) to Pembrolizumab for the Treatment of Renal Cell Cancer After Surgery

  • Phase 2
  • City of Hope Medical Center
  • About 62 people
  • Started Jul 8, 2026

In plain words A Phase 2 study of clostridium butyricum in people 18 and older, run by City of Hope Medical Center. It plans to enroll about 62 people at 2 US sites.

Who it lists and where

Who the trial lists, as registered

Lists people 18 and older. Conditions: Clear Cell Renal Cell Carcinoma; Sarcomatoid Renal Cell Carcinoma; Stage II Renal Cell Cancer AJCC v8; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8.

  • Be willing and able to provide informed consent for the trial
  • Histological confirmation of renal cell carcinoma (RCC) with a clear-cell or sarcomatoid component
  • Pathologic stage of pT2, G4 or sarcomatoid, N0M0; pT3, any grade, N0M0; pT4, any grade, N0M0; pTany, any grade, N+M0; or M1 no evidence of disease (NED) after resection
  • No prior systemic immunotherapy for RCC

9 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Biospecimen Collection; Clostridium butyricum CBM588 Strain; Computed Tomography; Pembrolizumab

Registered summary

This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. The full summary is on the listing.

Where, as registered

2 US sites in 1 state.

RecruitingNCT07167342

The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma

  • Phase 4
  • The Affiliated Hospital of Qingdao University
  • About 294 people
  • Started May 22, 2026

In plain words A Phase 4 study of clostridium butyricum in people 18 to 75, run by The Affiliated Hospital of Qingdao University. It plans to enroll about 294 people at 2 sites, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Colorectal Adenoma; Probiotics.

  • Age between 18 and 75 years
  • No restriction on sex
  • Boston Bowel Preparation Score (BBPS) ≥ 7 prior to endoscopic procedure
  • Completed endoscopic resection of colorectal adenomas (including cold snare polypectomy, ESD, EMR, etc.) with no residual adenomas or polyps observed endoscopically

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Clostridium butyricum capsules, Live; Control (placebo)

Registered summary

The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. The gut microbiota and its metabolic products are believed to play a potential role in the development and progression of colorectal adenomas. Clostridium butyricum, a butyrate-producing probiotic, has not yet been studied for its potential in preventing the recurrence of colorectal adenomas following resection. The full summary is on the listing.

Where, as registered

No US site; China (2).

RecruitingNCT07182890

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

  • Phase 4
  • Xijing Hospital of Digestive Diseases
  • About 180 people
  • Started Mar 26, 2026

In plain words A Phase 4 study of clostridium butyricum in people 18 to 80, run by Xijing Hospital of Digestive Diseases. It plans to enroll about 180 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 80. Conditions: Functional Dyspepsia; Probiotics; Depression; Anxiety.

  • Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.
  • Aged 18 to 80 years, regardless of gender.
  • Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.

The exclusion criteria are on the listing.

What it tests, as registered

Clostridium butyricum; placebo

Registered summary

Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. The full summary is on the listing.

Where, as registered

No US site; China (1).

RecruitingNCT05914389

Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

  • Phase 2
  • Second Affiliated Hospital, Zhejiang University, School of Medicine
  • About 100 people
  • Starts Aug 2023 (estimated)

In plain words A Phase 2 study of clostridium butyricum in people 18 to 75, run by Second Affiliated Hospital, Zhejiang University, School of Medicine. It plans to enroll about 100 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: Colon Neoplasm.

  • Age ≥18 years old and ≤75 years old.
  • Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma.
  • The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.
  • Enhanced CT stage T3/4 or T1-4N+ without multiple primary tumors or distant metastasis.

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Oxaliplatin; Capecitabine; Anti-PD-L1 Monoclonal Antibody; Clostridium butyricum; Colectomy

Registered summary

This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.

Where, as registered

No US site; China (1).

RecruitingNCT06696742

PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

  • Phase 2
  • The First Affiliated Hospital with Nanjing Medical University
  • About 60 people
  • Started Feb 1, 2024

In plain words A Phase 2 study of clostridium butyricum in people 18 and older, run by The First Affiliated Hospital with Nanjing Medical 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 and older. Conditions: Bladder (Urothelial, Transitional Cell) Cancer.

  • T2-T4aN0M0 bladder patients
  • Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.

The exclusion criteria are on the listing.

What it tests, as registered

Clostridium Butyricum Tablets; Cisplatin

Registered summary

This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer.

Where, as registered

No US site; China (1).

Not yet recruitingNCT07578025

Zanzalintinib and MO-03 for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy

  • Phase 2
  • City of Hope Medical Center
  • About 34 people
  • Starts Nov 28, 2026 (estimated)

In plain words A Phase 2 study of clostridium butyricum in people 18 and older, run by City of Hope Medical Center. It plans to enroll about 34 people at 1 US site.

Who it lists and where

Who the trial lists, as registered

Lists people 18 and older. Conditions: Metastatic Clear Cell Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8.

  • Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Age: ≥ 18 years

30 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Biospecimen Collection; Bone Scan; C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03; Computed Tomography; Zanzalintinib

Registered summary

This phase II trial tests how well zanzalintinib and MO-03 works for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progression) after receiving immunotherapy. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. MO-03 is a type of medication called a microbiome-based immunomodulator. It helps control some of the bacteria found in the gut which may make the zanzalintinib more effective. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Not yet recruitingNCT07152886

The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer

  • Phase 4
  • The Affiliated Hospital of Qingdao University
  • About 238 people
  • Starts Oct 31, 2025 (estimated)

In plain words A Phase 4 study of clostridium butyricum in people 18 to 70, run by The Affiliated Hospital of Qingdao University. It plans to enroll about 238 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: Colorectal Cancer; Chemotherapeutic Toxicity.

  • Aged 18-70 years;
  • No restriction on gender;
  • Have completed radical resection for colorectal cancer (including open, laparoscopic, or robotic surgery), and assessed by the MDT as requiring adjuvant therapy primarily based on 5-FU and its derivatives or platinum-based regimens…
  • ECOG performance status score of 0-2;

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Clostridium butyricum capsules; placebo capsules

Registered summary

This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer.

Where, as registered

No US site; China (1).

Not yet recruitingNCT07422103

PAN-CLO-BU (PANcreas-CLOstridium-BUtyricum)

  • No phase
  • Casa di Cura Dott. Pederzoli
  • About 158 people
  • Starts Mar 15, 2026 (estimated)

In plain words A study of clostridium butyricum in people 18 and older, run by Casa di Cura Dott. Pederzoli. It plans to enroll about 158 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: Pancreatic Cancer; Pancreatic Diseases; Gastrointestinal Symptoms; Clostridium Butyricum Miyairi; Pancreatoduodenectomy; CBM588.

  • Age ≥ 18 years
  • Written informed consent
  • Patients undergoing pancreaticoduodenectomy
  • Candidates for upfront surgery without previous neoadjuvant chemotherapy or radiotherapy

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Clostridium butyricum CBM588 Strain; Placebo

Registered summary

This is a prospective, randomized, double-blind, single-center clinical trial designed to evaluate the effects of Clostridium butyricum CBM588 supplementation on postoperative diarrhea, gastrointestinal symptoms, and quality of life in patients undergoing pancreaticoduodenectomy for periampullary neoplasms. Oncological outcomes, including disease-free survival and overall survival, will be monitored as secondary endpoints during follow-up.

Where, as registered

No US site; Italy (1).

Not yet recruitingNCT06992154

Role of Akkermansia Muciniphila in Acne Vulgaris

  • Early phase 1
  • Medical University of South Carolina
  • About 34 people
  • Starts Mar 2027 (estimated)

In plain words An early phase 1 study of clostridium butyricum in people 18 to 45, run by Medical University of South Carolina. It plans to enroll about 34 people and lists no sites yet.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 45. Conditions: Acne.

  • Participants aged 18 to 45 years.
  • Individuals with clinically diagnosed moderate to severe acne vulgaris, determined using standardized scales like the Global Acne Grading
  • System (GAGS) by Investigators of the study.
  • Willingness to provide informed consent and adhere to study protocols, including follow-ups and sample collections.

The exclusion criteria are on the listing.

What it tests, as registered

Akkermansia Muciniphila, Clostridium Beijerinckii, Anaerobutyricum Hallii, Clostridium Butyricum, Bifidobacterium Infantis Probiotic Capsule

Registered summary

The project explores the use of Pendulum's Glucose Control, which contains a unique combination of probiotics, including Akkermansia muciniphila, Clostridium beijerinckii, Anaerobutyricum hallii, Clostridium butyricum, and Bifidobacterium infantis, to treat acne by improving gut health and reducing inflammation. The full summary is on the listing.

Where, as registered

No sites listed yet.

ClinicalTrials.gov lists 21 open registrations for this search, including ones where clostridium butyricum is not a study arm or that are past the 10 we keep. Search them on ClinicalTrials.gov (opens in new tab).

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