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NCT01180725 · ClinicalTrials.gov registry record · Phase 4
Investigation of Dried Plums in the Treatment of Adults With Constipation
A Phase 4 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 4
- Development phase
NCT01180725 is a Phase 4 study that has completed, run by University of Iowa.
The verdict
NCT01180725, a Phase 4 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 4
- Development phase
Study Summary
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 supplem
Interventions
- DIETARY_SUPPLEMENT Dried Plum
- DIETARY_SUPPLEMENT Metamucil
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01180725
The ClinicalTrials.gov registry entry for NCT01180725 describes a study currently listed as completed, categorized as Phase 4. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dried Plum is the first listed.
NCT01180725 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01180725 about?
NCT01180725 is a clinical study titled "Investigation of Dried Plums in the Treatment of Adults With Constipation". 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...
What is the current status of trial NCT01180725?
This trial is currently completed. It is a Phase 4 study.
What interventions are being tested in trial NCT01180725?
The interventions under investigation include: Dried Plum (DIETARY_SUPPLEMENT), Metamucil (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01180725?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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