Actively Recruiting
Effects of Effera Human Lactoferrin at One Dose Compared to Placebo on Gut Permeability
Led by Helaina Inc. · Updated on 2025-06-25
46
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
H
Helaina Inc.
Lead Sponsor
B
Biofortis Mérieux NutriSciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 defined by waist circumference >40 inches in men or >35 inches in women
- Reports at least mild gastrointestinal symptoms based on a 7-day symptom questionnaire
- Non-user or former user of tobacco or nicotine products for at least 12 months and no plans to start during the study
- Non-habitual user of marijuana or hemp products and willing to abstain during the study (topical products allowed)
- Willing to use a smartphone capable of running the Cronometer app for diet records
- Willing to follow all study procedures and provide informed consent
You will not qualify if you...
- Clinically important gastrointestinal conditions that may interfere with study evaluation (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of weight loss surgery, gastroparesis, severe food intolerances or allergies)
- Endoscopy or colonoscopy preparation within 3 months prior to visit 1
- Abnormal laboratory test results of clinical significance at visit 1 without resolution after retesting
- Uncontrolled hypertension (systolic ≥140 mm Hg or diastolic ≥90 mm Hg) at visit 1
- Uncontrolled or clinically important pulmonary, cardiac, hepatic, renal, endocrine, hematologic, immunologic, neurologic, psychiatric, or biliary disorders
- Unstable use of prescription medications within 90 days before visit 1
- History or presence of cancer within past 2 years (except non-melanoma skin cancer)
- Major trauma or surgery within 3 months prior to visit 1
- Planned elective surgery during the study
- Active infection within 5 days of visit 1
- Diagnosis of tuberculosis or hepatitis within 1 year prior to study
- Extreme dietary habits as determined by Clinical Investigator
- Weight change greater than 4.5 kg in 3 months prior to visit 1
- Current or planned weight loss regimen during study
- Alcohol or substance abuse within 12 months prior to visit 1
- Antibiotic use within 3 months prior to visit 1 and during study
- Recent use of steroids or anti-inflammatory medications as specified
- Use of medications or supplements that influence gastrointestinal function within 2 weeks prior to visit 1 and during study
- Recent use of dietary supplements with bovine lactoferrin or excess iron within 60 days prior to visit 1
- Exposure to non-registered drug products within 1 month prior to visit 1 and during study
- Premenopausal females with irregular menstrual cycles or diagnosed with PMDD
- Females experiencing gastrointestinal symptoms only around menses
- Females who are pregnant, planning pregnancy, lactating, or unwilling to use approved contraception
- Females unwilling to adhere to birth control or wear a tampon during urine sample collection at menstruation
- Known allergy or intolerance to study products or excipients
- Any condition that may interfere with informed consent, study compliance, or interpretation of results as judged by the Clinical Investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Biofortis Inc
Addison, Illinois, United States, 60101
Actively Recruiting
Research Team
R
Ross Peterson, Ph.D.
CONTACT
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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