Search / Trial NCT06615986

Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

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

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Gut Barrier Intestinal Health Plasma Lipids Artherosclerosis Low Density Lipoprotein (Ldl) Cholesterol Lipoproteins Human Milk Oligosaccharides (Hmo) Gut Microbiota Symbiotic

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.

Trial Officials

Marcelo J Amar, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

About National Heart, Lung, And Blood Institute (Nhlbi)

The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0