Fiber Product for Gas, Bloating, and Bowel Regularity

This study is looking at a new fiber supplement called NutraLieve, which combines 8 different fibers. The goal is to see if NutraLieve can help with bloating, gas, and bowel regularity. Researchers believe the varied fibers might create a more diverse microbiome (the good bacteria in your gut), which could lead to less gut inflammation. You might be able to join if you are between 18 and 90 years old and have experienced symptoms like straining, hard stools, or a feeling of incomplete bowel movements for at least three months. The study will measure the number of bowel movements you have after 6 weeks to see how well the product works. The current recruitment status is unclear.

Study design: This is an interventional study planning to enroll 100 participants. It is testing a dietary supplement.
What's involved: Participants will be instructed to use the NutraLieve fiber product as labeled, starting with 4-5 grams per day.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome, number of bowel movements, will be measured at 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Fiber Product for Gas, Bloating, and Bowel Regularity

Not Yet Recruiting

NAAges 18–90InterventionalSupportive care

Bell Cinical Service

~100 participants

Updated 2024-10-15 on ClinicalTrials.gov

What's tested:Fiber supplement

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of bowel movement

Measured over 6 weeks

Conditions

Bloating

Bowel Irregularities

Bowel Gas

Where it's being run

1 sites across 1 states

Minnesota1

Who to contact

Robert Ganz, MD

[email protected]

802-272-7374

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

Number of bowel movement6 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.

Trialytics