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New treatment option for Healthy Volunteers
Official title Human Milk Oligosaccharide-Based Synbiotic Supplement for Intestinal Microbiota Dysbiosis
ClinicalTrials.gov ID: NCT06615986
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99. Healthy volunteers may be eligible.
You may be able to join if
- 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.
- people taking no medications, with a few exceptions (sporadic medication and medications known to not significantly affect the microbiome, per PI...
- Screening labs within normal levels. Deviations of the screening labs from normal levels up to CTCAE v5, grade 1 are allowed per PI discretion.
You likely can't join if
- Pregnancy or women currently breastfeeding.
- people currently on other prebiotics and/or probiotics supplementation.
- people that are vegetarians or vegans or not on a typical western diet.
- people planning to initiate new medications or already taking medications that may interfere or modify gut microbiome.
- people with allergy or known hypersensitivity to any components of the supplement.
- people with weight changes greater than 20% over the past 3 months.
See the full eligibility 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.
- people 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.
- Pregnancy or women currently breastfeeding.
- people currently on other prebiotics and/or probiotics supplementation.
- people that are vegetarians or vegans or not on a typical western diet.
- people planning to initiate new medications or already taking medications that may interfere or modify gut microbiome.
- people with allergy or known hypersensitivity to any components of the supplement.
- people with weight changes greater than 20% over the past 3 months.
- people planning a significant change in diet or exercise levels.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.