Status:
NOT_YET_RECRUITING
Adult HMO Supplementation and the Gut Microbiome
Lead Sponsor:
Seeding, Inc DBA Tiny Health
Collaborating Sponsors:
Mellitas Health Foods, LLC (DBA Layer Origin Nutrition)
Conditions:
Healthy Adults
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The goal of this study is to assess the impact of Layer Origin's SuperHMO prebiotic formulation on the healthy adult gut microbiome. Over the course of 30 days, intervention participants will take Sup...
Detailed Description
The investigators will enroll 24 healthy, adult volunteers into this double-blinded, randomized, placebo-controlled trial. Upon confirmation of eligibility and documentation of informed consent, the p...
Eligibility Criteria
Inclusion
- Participants are between the ages of 18 and 40.
Exclusion
- Participants cannot have taken prebiotic or probiotic supplements within 6 months of starting study. This includes prebiotic or probiotic powder or supplements with prebiotic or probiotic addition or multivitamin with probiotic addition. This does not include food with live probiotics in it like yogurt or kefir.
- Participants must not be pregnant or breastfeeding or trying to conceive within the study period.
- Participants must be residents of the United States with US postal service.
- Participants cannot have the following existing health conditions:
- Pre-existing gut conditions (IBD, Celiac's disease, Crohn's disease, SIBO)
- Immune or auto-immune conditions (Type 1 Diabetes, human immunodeficiency virus (HIV))
- Participants cannot be lactose intolerant or have an allergy to dairy products.
- Participants are excluded if they have received results from an at home microbiome stool test in the past 6 months. This does not include clinical workup such as culture or pathogen testing.
- Participants must agree not to take another prebiotic or probiotic supplement or an at-home test over the study period.
- Participants must have no known major dietary changes upcoming.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06570330
Start Date
September 1 2024
End Date
July 1 2025
Last Update
August 26 2024
Active Locations (1)
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1
Seeding Inc
Rockville, Maryland, United States, 20850