NCT06642766

Fiber Product for Gas, Bloating, and Bowel Regularity

Open Label Study of a Novel, Commercially Available Fiber Product for Gas, Bloating, and Bowel Regularity

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Bell Cinical Service · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bloating
• Bowel Irregularities
• Bowel Gas

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fiber supplement	Subjects that meet the inclusion criteria and with symptoms appropriate for fiber supplementation are eligible to participate. Participants will be instructed to use the fiber product (NutraLieve) as currently labeled; start with a dosage of 4-5 grams per day (one heaping teaspoon), initially taken once daily, increasing up to 3 heaping teaspoons a day (maximum dose 15 grams/day) on an as needed basis.Participants will be prospectively assessed for symptoms at baseline and at 6 weeks. * The primary endpoint, number of bowel movements, will be assessed by bowel movements in the last 72-hour period at baseline and at 6 weeks, by patient recall/diary. * Secondary endpoints, reduction in bloating or gas, or any adverse events will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: United States