- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03569527
Kiwifruit, Prunes, & Fiber for Abdominal and Bowel Symptoms in US Patients With Chronic Constipation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Presence of functional constipation according to modified ROME IV diagnostic criteria*5b i. Must include two or more of the following:
- Straining more than 25% of defecations
- Lumpy or hard stools more than 25% of defecations
- Sensation of incomplete evacuation more than 25% of defecations
- Sensation of anorectal obstruction/blockage more than 25% of defecations
- Manual manoeuvres to facilitate more than 25% of defecations (e.g. digital evacuation, support of pelvic floor)
- Fewer than three defecations per week ii. Loose stools are rarely present without the use of laxatives * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis For the purposes of this study, patients with abdominal pain will be included, but patients with severe pain (defined as average daily abdominal pain score of 7 or higher during the screening period) will be excluded. Patients with an appropriate level of GI symptoms despite taking stable doses (>3 months) of SSRI's, tricyclics or SNRIs will be allowed to enroll.
Exclusion Criteria:
Potential participants will be excluded if they have alarm features (GI bleeding, weight loss, unexplained iron deficiency anaemia, significant family history of colorectal cancer or IBD), anal fissures, significant chronic diseases (cardiovascular, cancer, renal failure, inflammatory bowel disease), previous gastrointestinal surgery (except appendectomy or cholecystectomy), neurological diseases (e.g. multiple sclerosis, spinal cord injury, CVA).
Patients taking opiates will not be eligible to participate. Women who are pregnant, breastfeeding or planning a pregnancy in the 2 months post selection (trial period) will be excluded.
As above, patients with severe IBS symptoms will be excluded (defined as average daily abdominal pain score of 7 or higher during the screening period).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kiwifruit
Treating chronic constipation with 2 kiwifruit (6g fiber) per day
|
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 for the 4 week intervention period.
|
Active Comparator: Psyllium fiber
Treating chronic constipation with 24g psyllium fiber (6g fiber) per day
|
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 psyllium fiber (24 g/day, fiber=6g/day) for the 4 week intervention period.
|
Active Comparator: Prune
Treating chronic constipation with 100g dried plums (6g fiber) per day
|
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 prunes/dried plums (100g, fiber=6 g/day) for the 4 week intervention period.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
: Change in complete spontaneous bowel movement (CSBM)
Time Frame: 8 weeks
|
Complete spontaneous bowel movement will be recorded.
This will be compared to the baseline, run-in periods, and follow-up period.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in SBM (spontaneous bowel movements)
Time Frame: 8 weeks
|
Spontaneous bowel movements will be recorded.
This will be compared to the baseline, run-in periods, and follow-up period.
|
8 weeks
|
stool consistency
Time Frame: 8 weeks
|
Bristol stool form scale (1-7, lower scores are consistent with constipation; higher scores are consistent with diarrhea) will be recorded.
This will be averaged and compared to the baseline, run-in period, and follow-up period.
|
8 weeks
|
straining
Time Frame: 8 weeks
|
5 point Likert scale for straining will be recorded (1-5, lower scores= less straining, higher scores = more straining).
This will be averaged and compared to the baseline, run-in periods, and follow-up period.
|
8 weeks
|
abdominal pain
Time Frame: 8 weeks
|
Daily score (0-10) for abdominal pain will be recorded (0=no pain, 10= severe pain).
This will be averaged and compared to the baseline, run-in periods, and follow-up period.
|
8 weeks
|
abdominal discomfort
Time Frame: 8 weeks
|
Daily score (0-10) for abdominal discomfort will be recorded (0=no pain, 10= severe pain).
This will be averaged and compared to the baseline, run-in periods, and follow-up period.
|
8 weeks
|
bloating
Time Frame: 8 weeks
|
Daily score (0-10) for abdominal bloating will be recorded (0=no pain, 10= severe pain).
This will be averaged and compared to the baseline, run-in periods, and follow-up period.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shanti Eswaran, MD, Department of Internal Medicine, Division of Gastroenterology, University of Michigan
Publications and helpful links
General Publications
- Chey SW, Chey WD, Jackson K, Eswaran S. Exploratory Comparative Effectiveness Trial of Green Kiwifruit, Psyllium, or Prunes in US Patients With Chronic Constipation. Am J Gastroenterol. 2021 Jun 1;116(6):1304-1312. doi: 10.14309/ajg.0000000000001149.
- Dimidi E, Staudacher HM. Could a kiwifruit a day keep the doctor away? Lancet Gastroenterol Hepatol. 2020 Jul;5(7):648. doi: 10.1016/S2468-1253(20)30163-1. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00127778
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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