Fiber Product for Gas, Bloating, and Bowel Regularity

NANot yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

May 31, 2025

Study Completion Date

May 31, 2025

Conditions
BloatingBowel IrregularitiesBowel Gas
Interventions
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."

Trial Locations (1)

55435

XL Medical, Edina

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

LX Medical

UNKNOWN

lead

Bell Cinical Service

INDUSTRY