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Assessing Changes in the Gut Microbiome of Non-Gastrointestinal Disordered Subjects Before and After Oral Prebiotic Supplementation Using the SIMBA Capsule

NCT07788924 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-27

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group clinical study. The primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of healthy participants without any known gastrointestinal disorders from baseline to endpoint in response to the prebiotic intervention (FiberSmart). The study population are adults (n=30) who will ingest either the FiberSmart or a matched Placebo daily for 21 days. Both products will be referred to as the Investigational Product (IP) in the study procedures section. While prebiotics are widely used for gut health, their specific impact on the small intestinal ecosystem remains largely uncharacterized compared to the large intestine. Understanding their impact on the upper GI tract can lead to new insights into their mechanisms of action. Given the critical role of the small intestine in metabolism and immunity, the study utilizes the SIMBA capsule to measure novel changes in the small intestine along with traditional measurements from stool samples.

Conditions

  • Prebiotics
  • Metagenomic Next Generation Sequencing
  • Microbiome
  • Small Intestine

Interventions

DRUG

FiberSmart

Anderson Global's FiberSmart Formulation, branded as FiberSmart, which is a soluble tapioca fiber powder (resistant dextrin). Natural Product Number 80091222. The product is a prebiotic supplement intended for oral consumption.

OTHER

Placebo

Placebo: Microcrystalline Cellulose, matches for appearance and taste, and is inert without prebiotic effects.

Sponsors & Collaborators

  • Anderson Advanced Ingredients

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788924 on ClinicalTrials.gov