Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

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).