NCT06615986

Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

Evaluation of a Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cardiosyn	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.

Timeline

• Start date: 2024-11-15
• Primary completion: 2027-04-15
• Completion: 2027-05-15
• First posted: 2024-09-27
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States