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

NCT03569527 | Completed

• 1 other identifier: HUM00127778
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Constipation

Keywords

Kiwifruit

Outcome Measures

Primary Outcomes (1)

• : 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 Outcomes (6)

• Change in SBM (spontaneous bowel movements)

  8 weeks

• stool consistency

  8 weeks

• straining

  8 weeks

• abdominal pain

  8 weeks

• abdominal discomfort

  8 weeks

Study Arms (3)

Kiwifruit

ACTIVE COMPARATOR

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

Dietary Supplement: Kiwifruit

Psyllium fiber

ACTIVE COMPARATOR

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

Dietary Supplement: Fiber

Prune

ACTIVE COMPARATOR

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

Dietary Supplement: Prunes

Interventions

Kiwifruit DIETARY_SUPPLEMENT

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.

Kiwifruit

Fiber DIETARY_SUPPLEMENT

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.

Psyllium fiber

Prunes DIETARY_SUPPLEMENT

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.

Also known as: Dried Plums

Prune

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• 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.

  PMID: 34074830 DERIVED

• 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.

  PMID: 32553145 DERIVED

MeSH Terms

Interventions

alcohol acyltransferase, Actinidia; Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shanti Eswaran, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 26, 2018
• Study Start: June 11, 2018
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)