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

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ClinicalTrials.gov Identifier: NCT03569527
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Shanti Eswaran, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Constipation Dietary Supplement: Kiwifruit Dietary Supplement: Fiber Dietary Supplement: Prunes Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Kiwifruit, Prunes, & Fiber for Abdominal and Bowel Symptoms in US Patients With Chronic Constipation
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Kiwifruit
Treating chronic constipation with 2 kiwifruit (6g fiber) per day
Dietary Supplement: Kiwifruit
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
Dietary Supplement: Fiber
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
Dietary Supplement: Prunes
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 Name: Dried Plums




Primary Outcome Measures :
  1. : 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Presence of functional constipation according to modified ROME IV diagnostic criteria*5b i. Must include two or more of the following:

  1. Straining more than 25% of defecations
  2. Lumpy or hard stools more than 25% of defecations
  3. Sensation of incomplete evacuation more than 25% of defecations
  4. Sensation of anorectal obstruction/blockage more than 25% of defecations
  5. Manual manoeuvres to facilitate more than 25% of defecations (e.g. digital evacuation, support of pelvic floor)
  6. 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569527


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Shanti Eswaran, MD Department of Internal Medicine, Division of Gastroenterology, University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanti Eswaran, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03569527    
Other Study ID Numbers: HUM00127778
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanti Eswaran, University of Michigan:
Kiwifruit
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive