Fiber Product for Gas, Bloating, and Bowel Regularity

Bell Cinical Service

Status: Not yet enrolling

Conditions: Bowel Irregularities; Bloating; Bowel Gas

Treatments: Dietary Supplement: Fiber supplement

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06642766

20243173

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Fiber supplemenmt

Experimental group

Treatment:

Dietary Supplement: Fiber supplement