Fiber Product for Gas, Bloating, and Bowel Regularity

Part of paid clinical trials in Edina, Minnesota.

Sponsor
Bell Cinical Service
Study ID
NCT06642766
Status
Not Yet Recruiting

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Conditions

  • Bloating
  • Bowel Gas
  • Bowel Irregularities

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Fiber supplement — DIETARY_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.

Study Details

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.

Key Dates

Start date
Oct 31, 2024
Status verified
Oct 2024
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Fiber supplemenmt

Primary Outcome Measure

Number of bowel movement [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
XL MedicalEdinaMinnesota55435
Robert Ganz, MD
[email protected]
802-272-7374
Aundria Riggen, PA
[email protected]
218-591-2958
Robert Ganz, MD

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XL Medical· Edina, MN

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