Fiber Product for Gas, Bloating, and Bowel Regularity (NCT06642766) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fiber Product for Gas, Bloating, and Bowel Regularity
United States100 participantsStarted 2024-10
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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 chron…