Fiber Product for Gas, Bloating, and Bowel Regularity

NCT06642766 | Not Yet Recruiting

• 1 other identifier: 20243173
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fiber supplement; bloating; nutralieve; Microbiome; Gut microbiota; irregular bowel movements

Outcome Measures

Primary Outcomes (1)

• Number of bowel movement

  \- 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.

  6 weeks

Secondary Outcomes (2)

• Bloating

  6 weeks

• Gas

  6 weeks

Study Arms (1)

Fiber supplemenmt

EXPERIMENTAL

Dietary Supplement: Fiber supplement

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.

Fiber supplemenmt

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects have experienced two or more of the following criteria for at least 3 months with symptom onset at least 6 months prior: straining during at least 25% of defecations, lumpy or hard stools in at least 25% of defecations, sensation of incomplete evacuation for at least 25% of defecations, sensation of anorectal obstruction/blockage for at least 25% of defecations, manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor), loose stools are rarely present without the use of laxatives Or,
• Subjects have experienced 2 or more of the following criteria of recurrent abdominal pain, for at least 3 months, with symptom onset at least 6 months prior: pain related to defecation, associated with a change in frequency of stool, associated with a change in form (appearance) of stool Or,
• Subjects have experienced 2 or more of the following criteria for at least 3 months, with symptom onset at least 6 months prior: recurrent abdominal pain, on average, at least 1 day per week in the last 3 months associated with two of the following criteria: pain related to defecation, pain associated with a change in frequency of stool and pain associated with a change in form (appearance) of stool.
• The subject predominantly experiences loose or watery stools (Bristol Stool Form Scale types 6-7), more than 25% of the time, or hard or lumpy stools (types 1-2) less than 25% of the time.
• The symptoms should be chronic and interfere with daily activities, cause worry or affect the quality of life.

You may not qualify if:

• Loose stools are present for more than 25% of defecations
• Unable to provide informed consent
• Hematochezia
• Prior colon surgery
• Thyroid disease
• Pelvic floor disorder
• Known allergies or intolerance to fiber products
• infectious diarrhea or food poisoning
• inflammatory bowel disease, including microscopic colitis
• fecal incontinence or rectal prolapse

Sponsors & Collaborators

• Bell Cinical Service: lead
• LX Medical: collaborator

Study Sites (1)

XL Medical

Edina, Minnesota, 55435, United States

Location

Central Study Contacts

Robert Ganz, MD

CONTACT

802-272-7374; bob@ganzindustries.com

Claudia Morr, MD

CONTACT

612-721-3976; morr.c@bellintlabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)