Status:
COMPLETED
Fibre and Gas in Irritable Bowel Syndrome
Lead Sponsor:
University of Nottingham
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief Summary
The aim of the study is to investigate how dietary fibre combinations affects gut physiology, particularly colonic gas production. Comparisons will be made between a single fermentable fibre (inulin),...
Detailed Description
The aim of the study is to investigate how dietary fibre combinations affects gut physiology, particularly colonic gas production. Comparisons will be made between a single fermentable fibre (inulin),...
Eligibility Criteria
Inclusion
- Ability to give informed consent
- Fulfilment of the Rome IV criteria for Irritable Bowel Syndrome for at least 3 months:
- Abdominal pain at least two or more days per week.
- Pain associated with two or more of the following:
- Related to defecation on at least ≥30% of occasions
- Associated with a change in frequency of stool on ≥30% of occasions
- Associated with a change in form (appearance) of stool on ≥30% of occasions
- Symptom onset at least 6 months prior to diagnosis
Exclusion
- Pregnancy declared by candidate
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Inability to lie flat or exceed scanner limits of weight \<120kg
- Unwilling to cease use of supplementary fibre or osmotic laxatives for the duration of the study
- Unable to stop drugs known to alter GI motility or transit including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists or osmotic laxatives for 2 days before, and during, MRI study days.
- Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria
- Reported alcohol intake of \>28 units/ week with daily drinking
- Intention to change smoking behaviour during the study
- History declared by the candidate of other pre-existing gastrointestinal disorders, including but not limited to:
- Inflammatory Bowel Disease
- Coeliac Disease
- Pancreatitis
- Gallstone disease (biliary colic, cholecystitis; asymptomatic presence of gallstones permitted)
- Complicated diverticulitis (asymptomatic presence of diverticula permitted)
- Cancer of the gastrointestinal tract
- Gastroparesis
- Other functional gastrointestinal disorders will be permitted as they frequently co-exist with IBS.
- Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy)
- Presence of an intestinal stoma
- Poor understanding of English language
- Participation of any medical trials for the past 3 months
- Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe COPD
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03265002
Start Date
March 8 2018
End Date
October 16 2019
Last Update
March 25 2020
Active Locations (1)
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1
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH