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Protocol Details

Evaluation of a Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001729-H

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Children;
Neonates;
Adults who are or may become unable to consent;
Pregnant Women

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Dietary Supplement: Cardiosyn

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

INCLUSION CRITERIA:

-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.

EXCLUSION CRITERIA:

-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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Marcelo J. Amar, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CLINICAL CENTER BG RM 5D03
10 CENTER DR
BETHESDA MD 20892
(301) 402-0521
mamar@mail.nih.gov

Joy Lynne V. Freeman
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 5-3140
10 Center Drive
Bethesda, Maryland 20892
(301) 480-7632
joylynne.freeman@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT06615986

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