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

Primary Purpose

Chronic Constipation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Kiwifruit

Fiber

Prunes

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Kiwifruit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Kiwifruit

Psyllium fiber

Prune

Arm Description

Treating chronic constipation with 2 kiwifruit (6g fiber) per day

Treating chronic constipation with 24g psyllium fiber (6g fiber) per day

Treating chronic constipation with 100g dried plums (6g fiber) per day

Outcomes

Primary Outcome Measures

: Change in complete spontaneous bowel movement (CSBM)

Complete spontaneous bowel movement will be recorded. This will be compared to the baseline, run-in periods, and follow-up period.

Secondary Outcome Measures

Change in SBM (spontaneous bowel movements)

Spontaneous bowel movements will be recorded. This will be compared to the baseline, run-in periods, and follow-up period.

stool consistency

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.

straining

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.

abdominal pain

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.

abdominal discomfort

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.

bloating

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.

Full Information

NCT ID

NCT03569527

First Posted

June 11, 2018

Last Updated

October 16, 2019

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT03569527

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 11, 2018 (Actual)

Primary Completion Date

October 10, 2019 (Actual)

Study Completion Date

October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Constipation

Keywords

Kiwifruit

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kiwifruit

Arm Type

Active Comparator

Arm Description

Treating chronic constipation with 2 kiwifruit (6g fiber) per day

Arm Title

Psyllium fiber

Arm Type

Active Comparator

Arm Description

Treating chronic constipation with 24g psyllium fiber (6g fiber) per day

Arm Title

Prune

Arm Type

Active Comparator

Arm Description

Treating chronic constipation with 100g dried plums (6g fiber) per day

Intervention Type

Dietary Supplement

Intervention Name(s)

Kiwifruit

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Fiber

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Prunes

Other Intervention Name(s)

Dried Plums

Intervention Description

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.

Primary Outcome Measure Information:

Title

: Change in complete spontaneous bowel movement (CSBM)

Description

Complete spontaneous bowel movement will be recorded. This will be compared to the baseline, run-in periods, and follow-up period.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change in SBM (spontaneous bowel movements)

Description

Spontaneous bowel movements will be recorded. This will be compared to the baseline, run-in periods, and follow-up period.

Time Frame

8 weeks

Title

stool consistency

Description

Time Frame

8 weeks

Title

straining

Description

Time Frame

8 weeks

Title

abdominal pain

Description

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.

Time Frame

8 weeks

Title

abdominal discomfort

Description

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.

Time Frame

8 weeks

Title

bloating

Description

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.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shanti Eswaran, MD

Organizational Affiliation

Department of Internal Medicine, Division of Gastroenterology, University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34074830

Citation

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.

Results Reference

derived

PubMed Identifier

32553145

Citation

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.

Results Reference

derived

Learn more about this trial

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

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