Lactoferrin trials recruiting now

9 registrations that name lactoferrin 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 9 registrations

Status

Phase

4US sites across 3 states

All 9 registrations

RecruitingNCT07524270

Effera Dose Response: Women's Health

  • No phase
  • Helaina Inc.
  • About 160 people
  • Starts Apr 2026 (estimated)

In plain words A study of lactoferrin in female participants 18 to 40, run by Helaina Inc.. It plans to enroll about 160 people at 2 US sites.

Who it lists and where

Who the trial lists, as registered

Lists female participants 18 to 40; healthy volunteers accepted. Conditions: Womens Health; Menstrual Symptoms.

  • Women, 18 - 40 years of age
  • No changes in hormonal contraception use in the past 6 months
  • Regular or mildly irregular cycles (24-45 days) for the past 3 months
  • In the majority (>3) of menstrual cycles over the past 6 months, experience menstrual cramps on a pain scale of at least 4 out of 10 (1=no pain at all and 10 = worst pain ever experienced)

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

What it tests, as registered

Effera® (human equivalent lactoferrin); Placebo

Registered summary

The goal of this clinical trial is to learn if a human equivalent lactoferrin supplement (effera®) can improve menstrual symptoms, mood, and quality of life in healthy women aged 18-40. The main questions it aims to answer are: Does effera® reduce the severity of menstrual symptoms? Does effera® improve mood, gastrointestinal symptoms, and overall well-being? Researchers will compare three different doses of effera® to a placebo (a look-alike supplement with no active ingredient) to see if the supplement improves these outcomes. The full summary is on the listing.

Where, as registered

2 US sites in 1 state.

RecruitingNCT07035964

Effects of Effera Human Lactoferrin at One Dose Compared to Placebo on Gut Permeability

  • No phase
  • Helaina Inc.
  • About 46 people
  • Started Jun 4, 2025

In plain words A study of lactoferrin in people 18 to 40, run by Helaina Inc.. It plans to enroll about 46 people at 1 US site.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 40; healthy volunteers accepted. Conditions: Gut Permeability; Gut Health.

  • Male or premenopausal female, 18 - 40 years of age, inclusive
  • BMI ≥ 18.5 to < 40.0 kg/m2
  • Abdominal adiposity defined by a waist circumference >40" in men or >35" in women measured at Visit 1.
  • Reports at least mild GI symptoms from the 7d GI Symptom Questionnaire collected at visit

The exclusion criteria are on the listing.

What it tests, as registered

human lactoferrin; Placebo

Registered summary

The purpose of this study is to evaluate the impact of 28-day supplementation with effera human lactoferrin, compared to a placebo control product on indicators of gut barrier health in males and females

Where, as registered

1 US site in 1 state.

RecruitingNCT07546591

A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females

  • No phase
  • Lindenwood University
  • About 30 people
  • Starts Apr 30, 2026 (estimated)

In plain words A study of lactoferrin in female participants 18 to 45, run by Lindenwood University. It plans to enroll about 30 people at 1 US site.

Who it lists and where

Who the trial lists, as registered

Lists female participants 18 to 45; healthy volunteers accepted. Conditions: Iron Deficiencies; Low Ferritin; Iron Deficiency; Exercise Performance of Fit Athletes.

  • Women, 18 - 45 years of age
  • No changes in hormonal contraception use in the past 6 months
  • Has a regular menstrual cycle defined as five out of the past six months
  • Engaging in ≥5 hours per week of structured endurance exercise (e.g., running, cycling, swimming, rowing) for the past ≥6 months, with ≥3 sessions per week at moderate-to-vigorous intensity (≥70% HRmax or RPE ≥13).

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

What it tests, as registered

Lactoferrin 100 mg; Lactoferrin 300 mg; Iron Supplementation (5 mg)

Registered summary

This randomized, double-blind, active-controlled trial will evaluate the effects of human lactoferrin supplementation combined with low-dose iron on iron status, aerobic performance, and lactate metabolism in exercising women with low ferritin. Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin \<35 µg/L will be enrolled in an 8-week intervention. Participants will be stratified by baseline ferritin status and randomized to receive 100 mg lactoferrin + 5 mg iron, 300 mg lactoferrin + 5 mg iron, or placebo + 5 mg iron daily. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

RecruitingNCT05519254

Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae

  • Phase 3
  • University of Washington
  • About 600 people
  • Started Mar 10, 2023

In plain words A Phase 3 study of lactoferrin in people 6 months to 24 months, run by University of Washington. It plans to enroll about 600 people at 4 sites, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 6 months to 24 months; healthy volunteers accepted. Conditions: Diarrhea; Wasting; Malnutrition, Child.

  • Age 6-24 months
  • Managed as an outpatient or inpatient for diarrhea at one of the recruiting sites
  • MUAC <12.5 cm at the time of screening
  • Plan to stay within the study area for the next 6 months or greater

The exclusion criteria are on the listing.

What it tests, as registered

Lactoferrin; Lysozyme; Lactoferrin + Lysozyme; Placebo

Registered summary

Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or "ORS"). The full summary is on the listing.

Where, as registered

No US site; Kenya (4).

RecruitingNCT05038462

Fetal Brain Care: Therapies for Brain Neurodevelopment in Fetal Growth Restriction

  • No phase
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer
  • About 304 people
  • Started Jan 18, 2023

In plain words A study of lactoferrin in female participants 18 and older, run by Institut d'Investigacions Biomèdiques August Pi i Sunyer. It plans to enroll about 304 people at 6 sites, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists female participants 18 and older. Conditions: Fetal Growth Retardation; Intrauterine Growth Restriction.

  • Singleton pregnancies
  • Non-malformed fetus
  • Pregnancies with fetal growth restriction
  • 24-32.6 weeks of gestation

The exclusion criteria are on the listing.

What it tests, as registered

Lactoferrin and DHA; Placebo

Registered summary

Singleton pregnancies being diagnosed of fetal growth restriction from 24 to 32.6 weeks of gestation will be randomized to two equally sized groups: maternal oral supplementation with Lactoferrin and DHA (Docosahexaenoic acid) or placebo.

Where, as registered

No US site; Spain (6).

RecruitingNCT07255742

Role of Lactoferrin in Prevention of Ventilator Associated Pneumonia in Neonates.

  • No phase
  • Dalia Mohamed Salah
  • About 120 people
  • Started Aug 1, 2025

In plain words A study of lactoferrin in people 0 days to 90 days, run by Dalia Mohamed Salah. It plans to enroll about 120 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists people 0 days to 90 days. Conditions: Ventilator Associated Pneumonia.

What it tests, as registered

Lactoferrin in prevention of VAP; Control

Registered summary

The aim of the study is to 1. Evaluate the preventive value of Lactoferrin on VAP among ventilated neonates. 2. Evaluate the Primary outcome of Lactoferrin on: Sepsis, Feeding intolerance, Vomiting, Constipation or diarrhea 3. Evaluate the effect of Lactoferrin in critically ventilated neonates on: Incidence of VAP Duration of mechanical ventilation Duration of hospital stay

Where, as registered

No US site; Egypt (1).

RecruitingNCT07764991

Lactoferrin Supplementation in Diabetic Nephropathy

  • Phase 2
  • Ain Shams University
  • About 60 people
  • Started Aug 1, 2025

In plain words A Phase 2 study of lactoferrin in people 18 to 75, 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 75. Conditions: Diabetic Nephropathy.

  • Age ≥ 18 years
  • Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min/1.73m2) or stage 4 (eGFR 15-29 ml/min/1.73m2)
  • Urinary albumin/Creatinine ratio (UACR): moderately and severely increased albuminuria (> 30 mg/g)
  • Stable standard therapy for at least three months prior to inclusion in the study.

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

What it tests, as registered

Lactoferrin; Antidiabetic; Placebo

Registered summary

Multiple pathways and mediators, including oxidative stress, inflammation, and the over-activity of the renin-angiotensin-aldosterone system are involved in the development of albuminuria and progression of diabetic nephropathy (DN), of which oxidative stress is the most prominent. Previous research has shown that lactoferrin (LF) has multi-pharmacological properties, including antioxidant, anti-inflammatory, antiviral, anticancer, antibacterial, antifibrotic and immunogenic properties . The full summary is on the listing.

Where, as registered

No US site; Egypt (1).

Not yet recruitingNCT06427200

Efficacy and Safety of Lactoferrin in Heart Failure Patients

  • Phase 4
  • Cairo University
  • About 114 people
  • Starts Jul 2024 (estimated)

In plain words A Phase 4 study of lactoferrin in people 18 to 65, run by Cairo University. It plans to enroll about 114 people and lists no sites yet.

Who it lists and where

Who the trial lists, as registered

Lists people 18 to 65. Conditions: Heart Failure With Reduced Ejection Fraction.

  • Age: 18-65 years old.
  • Chronic heart failure (> 6 months duration) with reduced ejection fraction defined as LVEF ≤ 40%.
  • NYHA-class II or III or IV with stable symptoms for at least the past 3 months.
  • Stabilized on beta blockers, renin-angiotensin system inhibitor (ACEI/ARB) or angiotensin receptor-neprilysin inhibitors (ARNIs), mineralocorticoid receptor antagonists (MRAs) and sodium-glucose co-transporter 2 Inhibitors (SGLT2i) and…

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

What it tests, as registered

oral Iron; Lactoferrin; lactoferrin and oral iron

Registered summary

This study will be conducted to determine the efficacy and safety of lactoferrin versus oral iron versus lactoferrin plus oral iron as an add on therapy in reduced ejection fraction heart failure patients with iron deficiency. •Patients will be randomly distributed into the three groups * All patients will be subjected to baseline data assessment * Follow up after 12 weeks

Where, as registered

No sites listed yet.

Not yet recruitingNCT07502235

The Effect of Lactoferrin on Pain Management Following Cesarean Section

  • Phase 3
  • Ain Shams University
  • About 90 people
  • Starts Mar 26, 2026 (estimated)

In plain words A Phase 3 study of lactoferrin in female participants 18 to 70, run by Ain Shams University. It plans to enroll about 90 people at 1 site, none in the US.

Who it lists and where

Who the trial lists, as registered

Lists female participants 18 to 70. Conditions: Cesarean Birth; Post Operative Analgesia.

  • Referred to elective (non-emergency) cesarean section
  • Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
  • Term gestational age

The exclusion criteria are on the listing.

What it tests, as registered

Lactoferrin; Placebo

Registered summary

This study evaluates whether lactoferrin, a naturally occurring protein with anti-inflammatory and antioxidant properties, can improve pain control after cesarean section. Effective management of postoperative pain is essential to support maternal recovery, mobility, and the ability to care for the newborn, while minimizing reliance on opioid medications and their associated side effects. The full summary is on the listing.

Where, as registered

No US site; Egypt (1).

ClinicalTrials.gov lists 19 open registrations for this search, including ones where lactoferrin is not a study arm or that are past the 9 we keep. Search them on ClinicalTrials.gov (opens in new tab).

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