FiberSmart for Gut Microbiome Health

Overseen By Isaac Wong

Age: 18 - 65

Sex: Male

Trial Phase: Phase 4

Sponsor: Nimble Science Ltd.

Must not be taking: PPIs, Metformin, Antibiotics, others

Disqualifiers: Gastrointestinal disease, Surgery, Alcohol, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am male or a female who is not pregnant, not breastfeeding, and at least 6 weeks postpartum.

At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study

I am between 19 and 40 years old.

Exclusion Criteria

I have fewer than three bowel movements each week.

I cannot stop taking my acid reflux medicine before and after the SIMBA capsule.

I have not had major digestive tract surgery or radiation that could block my intestines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants ingest either the FiberSmart or a matched Placebo daily for 21 days

3 weeks

Daily ingestion, with monitoring at baseline and endpoint

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FiberSmart

How Is the Trial Designed?

Group I: Prebiotic Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Nimble Science Ltd.

Lead Sponsor

Trials

11

Recruited

570+