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Prebiotic

SuperHMO Prebiotic for Gut Health

N/A
Waitlist Available
Research Sponsored by Seeding, Inc DBA Tiny Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants are between the ages of 18 and 40
Be between 18 and 65 years old
Must not have
Participants cannot have pre-existing gut conditions (IBD, Celiac's disease, Crohn's disease, SIBO)
Participants cannot have immune or auto-immune conditions (Type 1 Diabetes, human immunodeficiency virus (HIV))
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Summary

This trial aims to see how Layer Origin's SuperHMO prebiotic formulation affects the gut bacteria of healthy adults. Participants will either take the SuperHMO prebiotic or a placebo daily for

Who is the study for?
This trial is for healthy adults interested in participating in a study to evaluate the effects of a prebiotic supplement on gut health. Participants will be required to take a daily supplement or placebo and undergo gut health testing before and after the 30-day period.
What is being tested?
The study is testing Layer Origin's SuperHMO prebiotic formulation against a placebo (non-GMO corn Maltodextrin). The main goal is to see if SuperHMO improves gut microbiome health, specifically its ability to produce beneficial short-chain fatty acids over 30 days.
What are the potential side effects?
While not explicitly stated, potential side effects may include digestive discomfort such as bloating, gas, or changes in bowel habits due to alterations in the gut microbiome from taking the prebiotic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any pre-existing gut conditions like IBD, Celiac's, Crohn's disease, or SIBO.
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I do not have immune or autoimmune conditions like Type 1 Diabetes or HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess Changes in the diversity metrics of the Gut Microbiome
Detection of presence of specific HMO digestion genes
Evaluate Changes in Inflammation Markers
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention - SuperHMOExperimental Treatment1 Intervention
The investigation product is commercially available and is marketed as SuperHMO Prebiotic Mix with 5 HMOs. This product is a dietary supplement which contains five major types of human milk oligosaccharides includes 2'-Fucosyllactose (2'-FL), Lacto-N-tetraose (LNT), Lacto-N-neotetraose (LNnT), 6'-Sialyllactose (6'SL), and 3'-Sialyllactose (3'SL). SuperHMO is designed to boost the number and variety of beneficial bacteria in the gut by feeding them with five different kinds of human milk oligosaccharide prebiotics. This product does not contain any flavoring, colorants, preservatives or fillers. Each bottle contains 118 grams of the mix, 28 servings, with 4.2 grams per serving (2 scoops). Study participants will be instructed to take 1 scoop (2.1 g) per day for the first five days and increase to 2 scoops (4.2g) per day for days 6-30, the formulation can be dissolved in their beverage of choice and taken at any time of the day, with or without food.
Group II: ControlPlacebo Group1 Intervention
Control participants will receive a commercially available maltodextrin, NOW Sports Nutrition, Non-GMO corn Maltodextrin, Rapid Absorption. The composition and absorption properties are similar to the investigational product and will be given in the same dosage (2.1g/day for days 1-5 and increasing to 4.2 g/day for days 6-30) and route of administration as the investigational product. The use of maltodextrin as a comparator in prebiotic supplementation in human trials is well-documented.

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Who is running the clinical trial?

Seeding, Inc DBA Tiny HealthLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Mellitas Health Foods, LLC (DBA Layer Origin Nutrition)UNKNOWN
~16 spots leftby Nov 2024
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