Clinical trial NCT06642766: Fiber Product for Gas, Bloating, and Bowel Regularity
Official title: Open Label Study of a Novel, Commercially Available Fiber Product for Gas, Bloating, and Bowel Regularity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bloating
Bowel Irregularities
Bowel Gas
Keywords: fiber supplement
bloating
nutralieve
Microbiome
Gut microbiota
irregular bowel movements
Lead sponsor: Bell Cinical Service
Sponsor class: INDUSTRY
Collaborators: name: LX Medical
First posted: 2024-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of bowel movement
timeFrame: 6 weeks
Secondary outcomes:
measure: Bloating
timeFrame: 6 weeks
measure: Gas
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Edina
country: United States
facility: XL Medical
state: Minnesota
Study officials:
References: