Fiber Supplement for Digestive Issues

Overseen By Robert Ganz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bell Cinical Service

Disqualifiers: Thyroid disease, Pelvic floor disorder, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a new, commercially available, over-the-counter fiber supplement that combines 8 fibers. The varied nature of the fibers in this product is designed to create a more diverse microbiome (bacteria that live within the human GI tract). In general, the more diverse the microbiome the less inflammatory the gut. The purpose of this study is to evaluate the effects of a new fiber product on bloating, gas, and bowel movements.

Eligibility Criteria

This trial is for individuals experiencing abdominal bloating, flatulence, and constipation. Participants should be interested in trying a new fiber supplement to improve their gut health. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions.

Inclusion Criteria

My symptoms are long-lasting, affect my daily life, and lower my quality of life.

My bowel movements are mostly of a specific type.

I have had stomach pain or discomfort for at least 3 months, starting over 6 months ago.

Exclusion Criteria

Known allergies or intolerance to fiber products

I have a type of inflammatory bowel disease.

I experience loss of bowel control or have a rectal prolapse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the fiber supplement to evaluate its effects on bloating, gas, and bowel movements

6 weeks

Baseline and 6-week assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fiber Product

Trial Overview The study tests an over-the-counter fiber supplement that combines 8 different fibers aimed at diversifying the microbiome and reducing inflammation in the gut. The goal is to see if this product can alleviate symptoms of bloating, gas, and irregular bowel movements.

Participant Groups

Group I: Fiber supplemenmt Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bell Cinical Service

Lead Sponsor

Trials

1

Recruited

100+

LX Medical

Collaborator

Trials

1

Recruited

100+