Constipation Clinical Trial
Official title:
Evaluation of Changes in Gut Transit Time and Gastrointestinal Symptoms Following the Consumption of a Fiber Containing Product in Adults With Constipation
Gastrointestinal discomfort regularly affects >25% of the population worldwide. One of the
major contributors to GI discomfort is constipation, which has a prevalence of ~15% and
symptoms of which have a significant negative impact on the sufferer's quality of life. One
of the hallmarks of chronic constipation is slow progression of contents through the gut
(i.e. slow gut / colonic transit time), which may be associated with hard stools that are
difficult to expel.
Dietary fiber supplements are widely used as a first-line treatment for constipation
although little Level 1 evidence exists to support its use in adults. The effectiveness of
different fiber supplements is difficult to compare given wide differences in
water-retention capabilities and effects on the colonic microbial ecology. Given the
promising, yet largely unsubstantiated, benefits of fiber supplementation on symptoms of
functional constipation, the objective of this clinical trial is to evaluate tolerance and
effectiveness of four week supplementation of a fiber product, in a dose-ranging fashion, on
whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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