Healthy VolunteersEarly Phase 1NCT06615986
Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
A Early Phase 1 study testing Cardiosyn in people with Healthy Volunteers, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cardiosyn
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 28 Jul 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of a Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
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.
Read more
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.
Read the detailed description
Study Description:
This pilot proof-of-principle (PoP) study will investigate mechanisms of action of a human milk oligosaccharide (HMO)-based synbiotic supplement, Cardiosyn (a combination of prebiotics and pro-biotics). Synbiotics for gut microbiota are known to exert multiple beneficial effects, including anti-inflammatory and antioxidant actions, and normalizing blood lipids and iron markers in healthy human subjects.
Objectives:
Primary Objective:
To measure changes in microbiome determined by the increase of the population of Lactobacillus Plantarum and Bifidobacterium Bifidum.
Secondary Objectives:
Measure the level of adherence to the symbiotic supplementation.
Measure the effect of the synbiotic supplementation in plasma.
Measure the effect of synbiotic supplementation on gut integrity.
Tolerability and GI symptoms secondary to gut microbiome changes.
Tertiary/Exploratory Objectives:
Identify possible associations between the gut microbiome change and biomarkers.
Endpoints: Primary Endpoint:
At least an increase in the population of Lactobacillus Plantarum and Bifidobacterium Bifidum.
Secondary Endpoint:
Reported intake by the subject and counting the number of the remaining supplement
Biomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin, lipid profile and TMAO
Measurement of gut integrity marker (serum zonulin) in plasma
Number of participants that tolerated study supplement for full duration of study
Number of participants with GI reported symptoms according to CTCAE v5.0
Tertiary/Exploratory Endpoints:
Measurement of changes of microbiome and biomarkers in plasma (16S RNA microbiota analysis initially with potential for more extensive and novel analysis).
- Conditions
- Healthy Volunteers
- Being tested
- Cardiosyn
- Keywords
- Gut Barrier, Intestinal Health, PLASMA LIPIDS, Artherosclerosis, Low-Density Lipoprotein (LDL), Cholesterol, Lipoproteins, Human Milk Oligosaccharides (HMO), Gut Microbiota, Symbiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiosynDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Cardiosyn |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
Reported intake by the subject and counting the number of remaining supplement
Measure adherence to the symbiotic supplementation regimen.
Measured: 8 weeks
Mean change of biomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin in plasma
Assess the effect of synbiotic supplementation on plasma levels.
Measured: 8 weeks
Fold increase in Lactobacillus or Bifidobacterium over baseline
Evaluate the impact of synbiotic supplementation on gut integrity.
Measured: 8 weeks
Number of participants that tolerated symbiotic supllementation
Assess participant tolerabiltiy related to changes in the gut microbiome to synbiotic supplementation for duration of study
Measured: 8 weeks
Number of gastrointestinal symptoms reported by participants using Common Terminology Criteria for Adverse Events version 5.0
Gastrointestinal symptoms related to changes in the gut microbiome reported by participants using Common Terminology Criteria for Adverse Events version 5.0
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 Nov 2024
- Primary completion28 Jul 2026
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marcelo J Amar, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615986
- Sponsor's protocol ID
- 10001729
- Other IDs
- 001729-H
- Status last verified
- 8 Oct 2026
- First submitted
- 25 Sep 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication