Constipation Clinical Trial
Background: Constipation is a common problem that affects nearly 60 million Americans. The
treatment of constipation remains challenging with one half of patients dissatisfied with
current therapy. There is a need for a food-based, natural, convenient and tasty alternative
to the currently available OTC laxatives and fiber supplements, particularly for patients
with occasional and mild constipation. Dried plums and prune juice have been traditionally
used for the treatment of constipation but has not been systematically assessed in patients
with well defined constipation. Also, the efficacy, palatability and tolerability of dried
plums in the treatment of chronic constipation have not been examined.
Aim: To investigate and compare the effects of dried plums and psyllium on the overall
relief of constipation symptoms, taste and quality of life in adults with functional
constipation in a randomized crossover controlled trial.
Methods: We propose to study 40 subjects with functional constipation in a single blinded,
randomized, cross-over study comparing 3 weeks of dried plums with 3 weeks of treatment with
Psyllium
Data analysis: The primary outcome measure will be the global relief of constipation
symptoms as rated by the subject at the end of each phase of the study. Additionally, we
will assess several secondary outcome measures that will include the number of Complete
Spontaneous Bowel Movements (CSBM) per week, Quality of Life , psychological profile,
patient rating of taste on a VAS scale, patient rating of bloating, distension, satiety and
fullness and patient rating of constipation-related symptoms.
Expected Results: We anticipate that treatment with dried plums will improve symptoms of
constipation compared to the baseline. This improvement will be comparable to that achieved
with psyllium (Metamucil) treatment. Additionally, dried plums will offer a natural, food
based, convenient and more tasty alternative to over-the-counter laxatives and fiber
supplements.
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