NCT06615986 Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
| NCT ID | NCT06615986 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2027-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-11-15 with a primary completion date of 2027-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Marcelo J Amar, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT06615986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06615986 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06615986 currently recruiting?
Yes, NCT06615986 is actively recruiting participants. Contact the research team at joylynne.freeman@nih.gov for enrollment information.
Where is the NCT06615986 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06615986 clinical trial?
NCT06615986 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Marcelo J Amar, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 100 participants.