NCT07525739

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nimble Science Ltd. · Industry
• Sex: Male
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Canada