Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special supplement made from a natural sugar found in human milk. Researchers want to see if this supplement can help increase the good bacteria in the gut of healthy people and improve their heart health markers. The trial is looking for healthy volunteers aged 18 and older who eat a typical Western diet and are not taking any significant medications.

Participants in the study will visit the clinic twice. During the first visit, they'll undergo a blood test to see if they qualify and will be asked to collect a stool sample at home. If eligible, they will take the supplement, which is a powder mixed with a drink, twice a day for about eight weeks. After this period, participants will return for a second visit to repeat some tests and provide another stool sample. This study is currently recruiting, and they are keen to ensure the safety and health of all participants throughout the trial.

Gender

ALL

Eligibility criteria

• * 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.