Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

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).

• 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.