Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
- Conditions
- Healthy Volunteers
- Interventions
- Dietary Supplement: Cardiosyn
- Registration Number
- NCT06615986
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cardiosyn in Healthy Volunteers Cardiosyn 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.
- Primary Outcome Measures
Name Time Method Mean change in population of Lactobacillus plantarum and Bifidobacterium bifidum 8 weeks To assess changes in the microbiome, we will measure the increase in the populations of Lactobacillus plantarum and Bifidobacterium bifidum.
- Secondary Outcome Measures
Name Time Method Reported intake by the subject and counting the number of remaining supplement 8 weeks Measure adherence to the symbiotic supplementation regimen.
Mean change of biomarkers such as serum and fecal calprotectin, hs-CRP, serum iron, hepcidin, hemoglobin in plasma 8 weeks Assess the effect of synbiotic supplementation on plasma levels.
Fold increase in Lactobacillus or Bifidobacterium over baseline 8 weeks Evaluate the impact of synbiotic supplementation on gut integrity.
Number of participants that tolerated symbiotic supllementation 8 weeks Assess participant tolerabiltiy related to changes in the gut microbiome to synbiotic supplementation for duration of study
Number of gastrointestinal symptoms reported by participants using Common Terminology Criteria for Adverse Events version 5.0 8 weeks Gastrointestinal symptoms related to changes in the gut microbiome reported by participants using Common Terminology Criteria for Adverse Events version 5.0
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States