Effera human lactoferrin versus placebo for improving gut permeability

Randomized, Double-Blind, Placebo-Controlled, Parallel Study on the Effects of Effera Human Lactoferrin on Gastrointestinal Permeability

Try 28 days of Effera human lactoferrin versus a placebo to see if it improves gut barrier health in adults with mild GI symptoms and abdominal adiposity.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Helaina Inc. (Industry-sponsored)
• Locations: 1 site (Addison, Illinois)
• Trial ID: NCT07035964 on ClinicalTrials.gov

What this trial studies

This interventional study gives participants either Effera human lactoferrin or a placebo and follows them for 28 days to measure indicators of gut barrier health. Eligible participants are males or premenopausal females aged 18–40 with BMI 18.5–<40 and waist circumference criteria indicating abdominal adiposity, and who report at least mild GI symptoms. Biological samples will be collected to measure gut permeability markers, and samples may be retained for analyses such as lactoferrin absorption and immune biomarkers. The study is conducted at Biofortis in Addison, Illinois in collaboration with Helaina Inc. and Biofortis Mérieux NutriSciences.

Who should consider this trial

Good fit: Adults 18–40 who are male or premenopausal female with BMI 18.5–<40, waist circumference greater than 40 inches in men or greater than 35 inches in women, who report at least mild GI symptoms, who are non-users or former users of tobacco and not habitual marijuana users, and who can use a smartphone and comply with study visits are ideal candidates.

Not a fit: People outside the 18–40 age range, postmenopausal women, those with severe GI disease or ongoing tobacco or frequent marijuana use, or those unable to travel to Addison, Illinois are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the supplement could strengthen the gut barrier and reduce markers of intestinal permeability and related GI symptoms.

How similar studies have performed: Some preclinical and small clinical studies suggest lactoferrin can affect gut barrier and immune markers, but solid clinical evidence that it improves gut permeability in this specific adult population is limited.

Eligibility criteria

Inclusion Criteria:

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

2\. Mild GI symptoms will be defined as a combined weekly total score of gas/flatulence, abdominal distention/bloating, borborygmus/stomach rumbling, or burping symptoms ≥ 3.

5\. Non-user or former user (daily use; cessation ≥ 12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period.

6\. Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD/THC products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed).

7\. Willing to use personal smart phone with operating system (Android version 8.0 or newer; iOS version 15.5 or newer) capable of downloading the Cronometer app for diet records.

8\. Willing to adhere to all study procedures, including lifestyle considerations ,and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

Exclusion Criteria:

1. Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
2. Recent (≤ 3 months of visit 1) endoscopy or colonoscopy preparation.
3. Abnormal laboratory test results of clinical significance at visit 1, at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2, for participants with abnormal laboratory test results.
4. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1. Stable use of hypertension medication is allowed (defined as no change in medication regimen within the 90 days prior to Visit 1).
5. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions that are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
6. Unstable use (change in dose) of any prescription medications ≤ 90 d of visit 1, except for medications used PRN (e.g., asthma inhalers, non-drowsy seasonal allergy medications, etc.).
7. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
8. Major trauma or any surgical event within 3 months of visit 1.
9. Currently scheduled, or planning to schedule, an elective surgical procedure during the study.
10. Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. The visit may be rescheduled once all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to Visit 1. If an infection occurs during the study period, test visits will be rescheduled until signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to the scheduled study visits.
11. Diagnosis of tuberculosis of hepatitis within 1 year prior to study.
12. Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan/vegetarian) at the discretion of the Clinical Investigator.
13. Weight loss or gain \>4.5 kg in the 3 months prior to visit 1.
14. Currently or planning to be on a weight loss regimen during the study.
15. Recent history (≤ 12 months visit 1) of alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 11⁄2 oz distilled spirits).
16. Antibiotic use within 3 months of visit 1 and throughout the study period.
17. Recent use of oral or injectable steroids, or topical or inhaled steroids (≥ 1500 μg/d), ≤ 90 dof visit 1.
18. Regular use (≥ 3 days/week ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDS) and throughout the study period.
19. Use of medications (over-the-counter or prescription) and/or dietary supplements known to influence GI function, including but not limited to: pre-, post-, and probiotic supplements, fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and/or anti-spasmodic within 2 weeks of visit 1 and throughout the study period.
20. Recent use of dietary supplements containing bovine lactoferrin or iron in excess of the RDA (within 60 d of Visit 1). Standard multivitamin and mineral supplements are allowed.
21. Exposure to any non-registered drug product within 1 month of visit 1 and throughout the study period.
22. Pre-menopausal females with an irregular menstrual cycle (regular cycle defined as 21 to 35 days in length for the last 3 months prior to visit 1).
23. Female who is diagnosed with Premenstrual Dysphoric Disorder (PMDD).
24. Female who reports only experiencing GI symptoms around the time of menses.
25. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Women who become pregnant during the study will be discontinued.
26. Female who is unwilling to adhere to medically-recognized forms of birth control (e.g., hormonal and non-hormonal contraceptives, barrier methods, abstinence, etc).
27. Female who is unwilling to wear a tampon during the collection of urine samples when these collections occur during the time of menstruation.
28. Known sensitivity, intolerability, or allergy to any of the study products, study foods, or their excipients.
29. Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, and comply with the study protocol, which might confound the interpretation of the study results, or put the participant at undue risk.

Where this trial is running

Addison, Illinois

• Biofortis Inc — Addison, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Ross Peterson, Ph.D.

Conditions Gut Permeability; Gut Health