RECRUITING

Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-15
Study Completion:2027-05-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06615986

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy males and females between the ages 18 to 99.
  2. * Subject understands the protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
  3. * Subjects taking no medications, with a few exceptions (sporadic medication and medications known to not significantly affect the microbiome, per PI discretion).
  4. * Screening labs within normal levels. Deviations of the screening labs from normal levels up to CTCAE v5, grade 1 are allowed per PI discretion.
  1. * Pregnancy or women currently breastfeeding.
  2. * Subjects currently on other prebiotics and/or probiotics supplementation.
  3. * Subjects that are vegetarians or vegans or not on a typical western diet.
  4. * Subjects planning to initiate new medications or already taking medications that may interfere or modify gut microbiome.
  5. * Subjects with allergy or known hypersensitivity to any components of the supplement.
  6. * Subjects with weight changes greater than 20% over the past 3 months.
  7. * Subjects planning a significant change in diet or exercise levels.
  8. * Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.
  9. * Anticipated surgery during the study period.
  10. * Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant.

Contacts and Locations

Study Contact

Joy Lynne V Freeman
CONTACT
(301) 480-7632
joylynne.freeman@nih.gov
Marcelo J Amar, M.D.
CONTACT
(301) 402-0521
mamar@mail.nih.gov

Principal Investigator

Marcelo J Amar, M.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • Marcelo J Amar, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-15
Study Completion Date2027-05-15

Study Record Updates

Study Start Date2024-11-15
Study Completion Date2027-05-15

Terms related to this study

Keywords Provided by Researchers

  • Gut Barrier
  • Intestinal Health
  • PLASMA LIPIDS
  • Artherosclerosis
  • Low-Density Lipoprotein (LDL)
  • Cholesterol
  • Lipoproteins
  • Human Milk Oligosaccharides (HMO)
  • Gut Microbiota
  • Symbiotic

Additional Relevant MeSH Terms

  • Healthy Volunteers