Actively Recruiting
Randomized, Double-Blind, Placebo-Controlled Study of Effera Human Lactoferrin Effects on Gastrointestinal Permeability
Led by Helaina Inc. · Updated on 2025-06-25
46
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Helaina Inc.
Lead Sponsor
B
Biofortis Mérieux NutriSciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a 28-day supplementation with effera human lactoferrin compared to a placebo on gut barrier health in both males and females aged 18 to 40 years. The study aims to understand how this dietary supplement may impact indicators of gut permeability and overall gut health. Samples collected during the study will also be used to analyze lactoferrin absorption and immune biomarkers. Participants will be randomly assigned to receive either effera human lactoferrin or a placebo supplement in a double-blind manner. The study is designed as a parallel, placebo-controlled trial with masking to reduce bias. The intervention lasts for 28 days, and the primary measurement is the lactulose to mannitol ratio, which assesses gut permeability. Secondary outcomes include various markers of gut barrier function. Throughout the study, participants will be monitored for changes in gut permeability and gut barrier markers over four weeks. They will provide diet records using a smartphone app and undergo assessments including urine sample collections. The study includes safety monitoring and requires participants to adhere to lifestyle guidelines and study procedures. Overall participation lasts about one month, during which researchers will collect data to evaluate the supplement's effects.
CONDITIONS
Brief Title
Effects of Effera Human Lactoferrin at One Dose Compared to Placebo on Gut Permeability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or premenopausal female, aged 18 to 40 years inclusive
- Body mass index (BMI) between 18.5 and less than 40.0 kg/m2
- Abdominal adiposity with waist circumference over 40 inches for men or over 35 inches for women
- At least mild gastrointestinal symptoms based on a 7-day GI symptom questionnaire
- Non-user or former user of tobacco or nicotine products within last 12 months and no plans to start
- Non-habitual user of marijuana or hemp products and willing to abstain during the study
- Willing to use a smartphone capable of downloading the Cronometer app for diet records
- Willing to follow all study procedures and sign informed consent
You will not qualify if you...
- Clinically important gastrointestinal conditions that interfere with study evaluation (e.g., inflammatory bowel disease, IBS, Crohn's, celiac disease)
- Recent endoscopy or colonoscopy preparation within 3 months
- Abnormal lab test results of clinical significance at visit 1
- Uncontrolled hypertension (systolic ≥140 mm Hg or diastolic ≥90 mm Hg), stable medication use allowed
- Uncontrolled or clinically important pulmonary, cardiac, hepatic, renal, endocrine, hematologic, immunologic, neurologic, psychiatric, or biliary disorders
- Unstable use of prescription medications in last 90 days, except PRN use
- History or presence of cancer in prior 2 years except non-melanoma skin cancer
- Major trauma or surgery within 3 months
- Scheduled or planned elective surgery during the study
- Active infection signs or symptoms within 5 days prior to visit 1
- Tuberculosis or hepatitis diagnosis within 1 year
- Extreme dietary habits as determined by investigator
- Weight change over 4.5 kg in 3 months prior to visit 1
- Current or planned weight loss regimen during study
- Recent history of alcohol or substance abuse within 12 months
- Antibiotic use within 3 months before visit 1 and during study
- Recent steroid use within 90 days before visit 1
- Regular use of anti-inflammatory medications within 1 month before visit 1 and during study
- Use of medications or supplements that influence GI function within 2 weeks before visit 1 and during study
- Recent use of bovine lactoferrin or high-iron supplements within 60 days before visit 1
- Exposure to non-registered drug products within 1 month before visit 1 and during study
- Premenopausal females with irregular menstrual cycles or diagnosed PMDD
- Females only experiencing GI symptoms around menses
- Pregnant, planning pregnancy, lactating, or unwilling to use contraception during study
- Unwillingness to adhere to medically recognized birth control methods
- Unwillingness to wear a tampon during urine sample collection if menstruating
- Known allergies or intolerances to study products or foods
- Any condition that might interfere with informed consent, protocol compliance, or study safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive a single dose of effera human lactoferrin or placebo and are monitored for effects on gastrointestinal permeability.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Biofortis Inc
Addison, Illinois, United States, 60101
Actively Recruiting
Research Team
R
Ross Peterson, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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