Actively Recruiting

Early Phase 1
Age: 18Years - 99Years
All Genders
NCT06615986

Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-03-16

100

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males and females between the ages 18 to 99.
  • Understands the study protocol and provides written informed consent.
  • Willingness to comply with follow-up evaluations.
  • Taking no medications, with few exceptions (sporadic or those not significantly affecting microbiome).
  • Screening lab results within normal levels or minor deviations allowed per investigator discretion.
Not Eligible

You will not qualify if you...

  • Pregnancy or currently breastfeeding.
  • Taking other prebiotic or probiotic supplements.
  • Vegetarian, vegan, or not following a typical western diet.
  • Planning to start new medications or taking medications that may affect gut microbiome.
  • Allergy or known hypersensitivity to supplement components.
  • Weight changes greater than 20% in the past 3 months.
  • Planning significant diet or exercise changes.
  • Chronic diarrhea, gastric bypass, lap-band surgery, ostomies, bowel motility issues, or conditions affecting intestinal fat absorption.
  • Anticipated surgery during the study period.
  • Any condition judged by investigators to interfere with participation or safety.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

J

Joy Lynne V Freeman

CONTACT

M

Marcelo J Amar, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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