Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
Recruiting now · Early Phase 1
Conditions studied: Healthy Volunteers
In brief
Background: Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health. Objective: To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers. The supplement contains a natural sugar from human milk. Eligibility: Healthy people aged 18 years or older who eat a typical western diet. They must take no medications (with a few exceptions). Design: Participants will have 2 clinic visits. The first visit will start with screening. They will have a blood test and wait around 2 hours for the results of the blood test. The test will determine if they are eligible for the study. Eligible participants will have additional blood drawn during the screening visit. They will be given a kit to collect a stool sample at home with instructions. They may complete a 3-day food diary. They will meet with a nutritionist and a physician by phone, telehealth, or in person. The supplement is a powder that is mixed with water or another noncarbonated drink. Participants will drink 2 doses per day. Each dose will be 1 hour before or after a meal. The second visit will be about 8 weeks after the first. Participants may repeat the 3-day food diary and nutrition visit. The physical exam, blood tests, and stool sample will be repeated.
Key facts
- Study ID
- NCT06615986
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 100
- Starts
- 2024-11-15
- Expected to finish
- 2027-05-15
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Pregnancy or women currently breastfeeding.
- Subjects currently on other prebiotics and/or probiotics supplementation.
- Subjects that are vegetarians or vegans or not on a typical western diet.
- Subjects planning to initiate new medications or already taking medications that may interfere or modify gut microbiome.
- Subjects with allergy or known hypersensitivity to any components of the supplement.
- Subjects with weight changes greater than 20% over the past 3 months.
- Subjects planning a significant change in diet or exercise levels.
- Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.
- Anticipated surgery during the study period.
- Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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