Clinical trial NCT06570330: Adult HMO Supplementation and the Gut Microbiome
Official title: Assessing the Impact of Daily Supplementation of a Multi - Human Milk Oligosaccharide (HMO) Formulation on Adult Gut Microbiome Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Seeding, Inc DBA Tiny Health
Sponsor class: INDUSTRY
Collaborators: name: Mellitas Health Foods, LLC (DBA Layer Origin Nutrition)
First posted: 2024-08-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 SuperHMO prebiotic formulation daily. Control participants will take a placebo daily. We will measure all participants\&#39; gut microbiome using a gut health test before taking SuperHMO prebiotic or placebo and after 30 days of taking the supplement. We hypothesize that taking the SuperHMO prebiotic will improve gut health measurements such as the potential to produce short-chain fatty acids.

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 participants will be randomized to either SuperHMO (Layer Origin, 53% 2'FL, 15% LNT, 14%LNnT, 12% 6'SL, 6% 3'SL) prebiotic formulation at a dosage of (4.2 g/day) or placebo (maltodextrin, 4.2 g/day), self-administered at home and taken as a liquid solution in a beverage of choice by mouth once daily for 30 days. Participants will take a baseline survey at the beginning of the study and an exit survey at the end of the study assessing their current health, health history, diet, current and past supplement and medication use, and any GI symptoms or bowel irregularities. Participants will additionally take a baseline microbiome sample before beginning the daily regimen of taking the supplement or placebo for 30 days. At the end of the study, participants will take another microbiome sample and an exit survey to report changes to gut health, overall health, diet, and any adverse reactions. Gut microbiome outcomes will be analyzed both intra-individually, as a before and after comparison, and inter-individually to compare intervention and control groups.

Eligibility criteria: Inclusion Criteria:

* Participants are between the ages of 18 and 40.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Quantitative changes in the relative abundance of key bacterial taxa
timeFrame: 30 days
measure: Detection of presence of specific HMO digestion genes
timeFrame: 30 days
measure: Assess Changes in the diversity metrics of the Gut Microbiome
timeFrame: 30 days
measure: Evaluate Changes in Metabolic Markers
timeFrame: 30 days
measure: Evaluate Changes in Inflammation Markers
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Seeding Inc
state: Maryland
Study officials:
References: