Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

NCT06615986 | Recruiting Early Phase 1

• 2 other identifiers: 10001729001729-H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy Volunteers

Keywords

Gut Barrier; Intestinal Health; PLASMA LIPIDS; Artherosclerosis; Low-Density Lipoprotein (LDL); Cholesterol; Lipoproteins; Human Milk Oligosaccharides (HMO); Gut Microbiota; Symbiotic

Outcome Measures

Primary Outcomes (1)

• Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum

  To assess changes in the microbiome, we will measure the increase in the populations of Lactobacillus plantarum and Bifidobacterium bifidum.

  8 weeks

Secondary Outcomes (5)

• Reported intake by the subject and counting the number of remaining supplement

  8 weeks

• Mean change of biomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin in plasma

  8 weeks

• Fold increase in Lactobacillus or Bifidobacterium over baseline

  8 weeks

• Number of participants that tolerated symbiotic supllementation

  8 weeks

• Number of gastrointestinal symptoms reported by participants using Common Terminology Criteria for Adverse Events version 5.0

  8 weeks

Study Arms (1)

Cardiosyn in Healthy Volunteers

EXPERIMENTAL

Participants will receive 2 doses of Cardiosyn daily by mouth (2 sachets) for a total of 16.2 grams. Each does (sachet) is 8.1 grams.

Dietary Supplement: Cardiosyn

Interventions

Cardiosyn DIETARY_SUPPLEMENT

Two sachets by mouth daily. Each dose (sachet) is 8.1 grams. For 2 doses it will be 16.2 grams per person per day.

Cardiosyn in Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females between the ages 18 to 99.
• Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
• Subjects taking no medications, with a few exceptions (sporadic medication and medications known to not significantly affect the microbiome, per PI discretion).
• Screening labs within normal levels. Deviations of the screening labs from normal levels up to CTCAE v5, grade 1 are allowed per PI discretion.

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Marcelo J Amar, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy Lynne V Freeman

CONTACT

(301) 480-7632; joylynne.freeman@nih.gov

Marcelo J Amar, M.D.

CONTACT

(301) 402-0521; mamar@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting approximately 6 months after publication and available indefinitely.
• Access Criteria: Data will be shared through the NHLBI BioData Catalyst, which is a controlled access repository.

Locations

US (1)