Kiwifruit Ingestion to Normalise Gut Symptoms in the Christchurch IBS cohort

Not Applicable

• Conditions: Functional Constipation; Constipation-predominant Irritable Bowel Syndrome; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621000621819
• Lead Sponsor: icole Roy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adult with FC or IBS-C (18-65 years) with a BMI between 18 and 35kg/m2.

A. The FC participants will be selected based on the following criteria:
Presence of FC according to Rome IV Diagnostic Criteria (fulfilled for the last three months with symptom onset at least six months prior to diagnosis):
1. Must include two or more of the following:
- Straining during more than 25% of defecations
- Lumpy or hard stools during more than 25% of defecations
- Sensation of incomplete evacuation for more than 25% of defecations
- Sensation of anorectal obstructions/blockage for more than 25% of defecations
- Manual manoeuvres to facilitate more than 25% of defecations (e.g. digital evacuation, support of the pelvic floor)
- Fewer than three complete spontaneous bowel movements per week

2. Loose stools are rarely present without the use of laxatives
3. Insufficient criteria for irritable bowel syndrome

The participants with mild IBS-C will be selected based on the following Rome IV Diagnostic Criteria (fulfilled for the last three months with symptom onset at least six months prior to diagnosis):
1. Recurrent abdominal pain, on average, at least one day per week in the last three months, associated with two or more of the following:
- Related to defecation
- Associated with a change in frequency of stool
- Associated with a change in form (appearance) of stool

2. More than 25% of bowel movements with Bristol Stool form types 1 or 2 and less than 25% of Bowel movements of types 6 or 7.

Exclusion Criteria

- Inability to give informed consent
- Pregnancy, breastfeeding or planning a pregnancy in the three months post-selection (study time frame)
- Alarm features associated with bowel habits, such as recent changes in bowel habits (onset less than three months), rectal bleeding, sudden weight loss, occult blood in stool, anaemia, anal fissures, bleeding haemorrhoids, and family history of gastrointestinal cancer at a young age or Irritable Bowel Disease (IBD)
- Known significant gastrointestinal disorder and disease other than IBS-C, diverticulitis, coeliac disease, IBS-D or mixed IBS, or previous bowel resection.
- Known systemic disease that could influence the gut directly or through medication use (e.g. diabetes, opiate or NSAID use)
- Chronic disease such as cardiovascular, cancer, renal failure, previous gastrointestinal surgery other than cholecystectomy or appendectomy, neurological conditions such as multiple sclerosis, spinal cord injury, or stroke
- Fasting blood glucose equals to or more than 6.0 mmol/l
- Known kiwifruit or latex allergy
- Inability to swallow pills
- Inability to access MRI machines such as presence of pacemakers or cochlear implants
- Laxative use and inability or unwillingness to stop laxative use for the seven days before sample collections.
- An IBS Severity Index score of over 300.
- Indication of inability to comply with the study procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified