Investigation of Dried Plums in the Treatment of Adults With Constipation
|ClinicalTrials.gov Identifier: NCT01180725|
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : August 12, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Dietary Supplement: Dried Plum Dietary Supplement: Metamucil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180725
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|