Kiwifruit, Prunes, & Fiber for Abdominal & Bowel Symptoms in US Patients

Status Completed

Clinical Trial Summary

This is a parallel group pilot study comparing the efficacy green kiwifruit, prunes or psyllium on abdominal and bowel related symptoms in US patients with chronic constipation patients.

Clinical Trial Description

Chronic constipation and Irritable Bowel Syndrome with constipation are common gastrointestinal disorders which negatively impact quality of life, reduce work productivity, and account for significant direct and indirect costs. Patients with CC and IBS-C suffer with bowel symptoms such as reduced stool frequency, hard stool consistency, straining or a sensation of incomplete evacuation. Coupled with barriers which limit access to expensive prescription increasing concerns regarding the long-term safety of chronically dosed medications and, there has been an increasing demand for more "natural" solutions to a wide range of medical conditions, including CC and IBS-C. Green kiwifruit has long been used as a natural remedy to improve GI complaints. A growing body of literature supports the benefits of kiwifruit for gut health and in particular, abdominal discomfort and bowel regularity. In addition, patients are interested in dietary changes that could improve their symptoms The investigators propose a parallel group pilot study comparing the efficacy green kiwifruit, prunes or psyllium on abdominal and bowel related symptoms in US patients with chronic constipation patients. The investigators plan to recruit chronic constipation patients with or without pain. The total duration of the study will be 8 weeks (2- week baseline, 4-week intervention, and 2-week follow-up). Eligible patients will be randomized to receive kiwifruit (2 green kiwifruit per day, psyllium (12 g b.d./day, fiber=6g/day) or dried plums (50 g b.d., fiber=6 gm/day) for the 4 week intervention period. It is expected that Kiwifruit will offer greater efficacy than psyllium and prunes for abdominal and bowel symptoms in US patients with chronic constipation. This will be the first US data addressing the efficacy of Kiwifruit for abdominal and bowel symptoms in patients with chronic constipation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03569527
Study type	Interventional
Source	University of Michigan
Contact
Status	Completed
Phase	N/A
Start date	June 11, 2018
Completion date	October 10, 2019

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Kiwifruit, Prunes, & Fiber for Abdominal and Bowel Symptoms in US Patients With Chronic Constipation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms