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Compares treatment options for Gut Permeability
Official title Effects of Effera Human Lactoferrin at One Dose Compared to Placebo on Gut Permeability
ClinicalTrials.gov ID: NCT07035964
What this study is testing
- What it's testing
- 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
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join 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 2\. Mild GI symptoms will be defined as a combined weekly...
You likely can't join if
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease...
- 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...
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at...
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease...
- 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...
See the full eligibility criteria
Who can join
- 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 2\. Mild GI symptoms will be defined as a combined weekly total score of gas/flatulence, abdominal distention/bloating...
What rules you out
- 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...
- 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...
- 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...
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease...
- 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...
- 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).
- Antibiotic use within 3 months of visit 1 and throughout the study period.
- Recent use of oral or injectable steroids, or topical or inhaled steroids (≥ 1500 μg/d), ≤ 90 dof visit 1.
- Regular use (≥ 3 days/week ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDS) and throughout the study period.
- 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...
- 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.
- Exposure to any non-registered drug product within 1 month of visit 1 and throughout the study period.
- 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).
- Female who is diagnosed with Premenstrual Dysphoric Disorder (PMDD).
- Female who reports only experiencing GI symptoms around the time of menses.
- 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...
- Female who is unwilling to adhere to medically-recognized forms of birth control (e.g., hormonal and non-hormonal contraceptives, barrier methods, abstinence, etc).
- Female who is unwilling to wear a tampon during the collection of urine samples when these collections occur during the time of menstruation.
- Known sensitivity, intolerability, or allergy to any of the study products, study foods, or their excipients.
- 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 study team makes the final eligibility decision.
Where it's taking place
- Addison, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Addison, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.