Fiber Product for Gas, Bloating, and Bowel Regularity

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bloating; Bowel Irregularities; Bowel Gas
• Intervention / Treatment: Dietary supplement: Fiber supplement

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Ganz, MD; Phone Number: 802-272-7374; Email: bob@ganzindustries.com
• Study Contact Backup: Name: Claudia Morr, MD; Phone Number: 612-721-3976; Email: morr.c@bellintlabs.com

Study Locations

• United States
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • XL Medical
      • Contact: Robert Ganz, MD; Phone Number: 802-272-7374; Email: bob@ganzindustries.com
      • Contact: Aundria Riggen, PA; Phone Number: 218-591-2958; Email: aundria@lx-medical.com
      • Contact: Robert Ganz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fiber supplemenmt

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bloating	- Reduction in bloating will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary.	6 weeks
Gas	Reduction in gas will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary.	6 weeks

Collaborators and Investigators

• Sponsor: Bell Cinical Service
• Collaborators: LX Medical

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Microbiome; Gut microbiota; bloating; fiber supplement; nutralieve; irregular bowel movements
• Other Study ID Numbers: 20243173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Subject's demographics and measured outcomes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No