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NOT YET RECRUITING
NCT07525739
PHASE4

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

Sponsor: Nimble Science Ltd.

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

19 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-07-20

Completion Date

2026-12-20

Last Updated

2026-07-10

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Life Science Innovation Hub

Calgary, Alberta, Canada