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

NCT07035964 | Recruiting DMC

• 1 other identifier: BIO-2504
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gut Permeability; Gut Health

Outcome Measures

Primary Outcomes (1)

• lactulose to mannitol ratio

  Change from baseline of lactulose to mannitol ratio

  0, 4 weeks

Secondary Outcomes (1)

• Markers of gut barrier function

  0, 4 weeks

Other Outcomes (1)

• Questionnaire of women's health

  0, 4 weeks

Study Arms (2)

Dietary supplement: effera human lactoferrin

EXPERIMENTAL

Dietary supplement: effera human lactoferrin

Dietary Supplement: human lactoferrin

Dietary Supplement: Placebo Control

PLACEBO COMPARATOR

Dietary Supplement: Placebo Control

Dietary Supplement: Placebo

Interventions

human lactoferrin DIETARY_SUPPLEMENT

effera human lactoferrin

Also known as: effera

Dietary supplement: effera human lactoferrin

Placebo DIETARY_SUPPLEMENT

Placebo Control

Also known as: Control

Dietary Supplement: Placebo Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• \. 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.
• \. 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.
• \. 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).
• \. 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.
• \. 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.

You may not qualify if:

• 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).
• Recent (≤ 3 months of visit 1) endoscopy or colonoscopy preparation.
• 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.
• 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).
• 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.
• 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.).
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• Major trauma or any surgical event within 3 months of visit 1.
• Currently scheduled, or planning to schedule, an elective surgical procedure during the study.
• 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.
• Diagnosis of tuberculosis of hepatitis within 1 year prior to study.
• Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan/vegetarian) at the discretion of the Clinical Investigator.
• Weight loss or gain \>4.5 kg in the 3 months prior to visit 1.
• Currently or planning to be on a weight loss regimen during the study.
• 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).

Sponsors & Collaborators

• Helaina Inc.: lead
• Biofortis Mérieux NutriSciences: collaborator

Study Sites (1)

Biofortis Inc

Addison, Illinois, 60101, United States

RECRUITING

Central Study Contacts

Ross Peterson, Ph.D.

CONTACT

7204097993; ross@myhelaina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 25, 2025
• Study Start: June 4, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (1)