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NCT Number: NCT06642766

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.

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Key information

Conditions

Bloating Bowel Gas Bowel Irregularities

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of bowel movement

    Time frame: 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 outcomes

  1. Bloating

    Time frame: 6 weeks

    • Reduction in bloating will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary.

  2. Gas

    Time frame: 6 weeks

    Reduction in gas will be assessed using analog scales, also by 72-hour recall at baseline and at 6 weeks, by patient recall/diary.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Morr, MD

CONTACT

[email protected]

612-721-3976

Robert Ganz, MD

CONTACT

[email protected]

802-272-7374

Sponsors and collaborators

Lead sponsor

Bell Cinical Service

Industry

Collaborators

  • LX Medical

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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