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

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569527
• Other study ID #: HUM00127778
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: October 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	: 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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks