Synbiotic Supplement for Gut Health
Trial Summary
Will I have to stop taking my current medications?
Participants must not be taking any medications, with a few exceptions for sporadic medication and those that do not significantly affect the gut microbiome. If you are currently on medication, you may need to stop, unless it falls under these exceptions.
What data supports the effectiveness of the treatment Human Milk Oligosaccharide-Based Synbiotic Supplement for gut health?
Research shows that human milk oligosaccharides (HMOs) can increase beneficial bacteria in the gut, improve gut barrier function, and reduce inflammation, which suggests they may help with gut health. These benefits have been observed in infants and adults, indicating potential effectiveness for gut health in other age groups as well.12345
Is the synbiotic supplement safe for humans?
How is the HMO-Based Synbiotic Supplement treatment different from other gut health treatments?
The HMO-Based Synbiotic Supplement is unique because it uses human milk oligosaccharides (HMOs), which are naturally found in breast milk and act as prebiotics to promote beneficial gut bacteria. Unlike other treatments, HMOs also enhance immune function and support brain development, making them a novel option for improving gut health.12367
What is the purpose of this trial?
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.
Research Team
Marcelo J Amar, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria
This trial is for healthy adults over 18 who typically eat a western diet and are not on medications, with some exceptions. They should be willing to visit the clinic twice, provide blood and stool samples, complete a food diary, and consult with a nutritionist.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the synbiotic supplement, Cardiosyn, for 8 weeks. They will drink 2 doses per day, each dose being 1 hour before or after a meal.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including repeating physical exams, blood tests, and stool sample collection.
Treatment Details
Interventions
- Human Milk Oligosaccharide-Based Synbiotic Supplement
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor