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Could a Milk-Sugar supplement boost your gut bacteria?

NCT ID NCT06615986

Knowledge-focused Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily supplement called Cardiosyn can increase helpful gut bacteria in healthy adults who eat a typical Western diet. The supplement contains a natural sugar found in human milk along with probiotics. One hundred participants will take the powder for about 8 weeks, and researchers will measure changes in their gut bacteria and blood markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cardiosyn (a synbiotic dietary supplement containing human milk oligosaccharides and probiotics)
What this could lead to
If it works, this could point toward a simple supplement to improve gut health and reduce heart disease risk in healthy people.
What could go wrong
This is a very early, small study in healthy volunteers, so results may not apply to people with illnesses. The supplement may cause digestive discomfort or show no clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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