The Christchurch IBS cohort to investigate mechanisms for gut relief and improved transit - Psyllium and Kiwifruit translation study

Not Applicable

Completed

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

• Registration Number: ACTRN12618001286235
• Lead Sponsor: niversity of Otago, Christchurch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-31
• Study Completion: 2019-12-23
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Healthy volunteers without FC/IBS for the control group, and
presence of functional constipation according to ROME IV Diagnostic Criteria or presence of mild IBS-C based on the Rome IV Diagnostic Criteria for the IBS/FC group.

We used participants without IBS/FC for the COMFORT cohort, to be able to compare data (biological and questionnaire) from a healthy digestion to disordered digestion. These are the two groups.
However, in this feasibility study, both groups will be analysed in regards to baseline , during both interventions, and during wash out and follow up, since we are interested how digestion may change in both groups over time in a future clinical trial.

Exclusion Criteria

a BMI under 18 or over 35
uncontrolled diabetes
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 habit, 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 GI cancer at a young age or IBD
Known significant gastrointestinal disorder other than IBS-C, such as IBD, diverticulitis, coeliac disease, or previous bowel resection
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 of over 6.0 mmol/l
Known kiwifruit or latex allergy
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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified