Status:
COMPLETED
Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)
Lead Sponsor:
King's College London
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
Universidad Veracruzana
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The aim of the study is to investigate how different dietary fibre combinations affects physiological and microbiological outcomes, in addition to symptoms in those with IBS. The study will also explo...
Detailed Description
Currently, national and international guidelines are based upon trials of dietary fibre in IBS symptoms that report opposing effects. For this reason, recommendations regarding dietary fibre food supp...
Eligibility Criteria
Inclusion
- Interested in taking part
- Ability to give informed consent
- Men and women aged 18-65 years with diarrhoea-predominant IBS (IBS-D), constipation-dominant IBS (IBS-C), or mixed (IBS-M), based on fulfilment of the Rome IV criteria for irritable bowel syndrome who do not have a major medical condition (e.g. diabetes, psychiatric or current eating disorders), severe oesophagitis, gastritis or duodenitis, gastrointestinal disease (inflammatory bowel disease, coeliac disease, active diverticulitis), or history of previous GI surgery (excluding appendicectomy, cholecystectomy and haemorrhoidectomy), severe renal, cardiac, pulmonary, or other chronic diseases likely to affect motility, history of gastric bezoars.
Exclusion
- Females who report to be pregnant or lactating
- Body Mass Index (BMI) \>40 kg/m2
- Use of unpermitted medications in the last 4 weeks prior to, or during the study including: Antibiotics within the last 4weeks, dietary fibre food supplements within the last 4 weeks (e.g. Fybogel, Lactulose), prebiotics or probiotics (in food products or as supplements) within the last 4 weeks, other dietary supplements that may affect the luminal microenvironment of the intestine (e.g. Orlistat)
- Use of drugs known to alter GI motility, transit or gastric pH (e.g. mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines) in the last 1 week
- Full bowel preparation for a diagnostic procedure within the last 4 weeks
- Changes to IBS medications or dose in the 4 weeks prior to the study
- Changes to anti-depressant medications or dose in the 12 weeks prior to the study
- Swallowing disorders (physical or psychological)
- Use of implantable and/or medical devices such as pacemakers
- Individuals following extreme diets e.g. 8 or more caffeinated serves per day, 4 or more bottles of wine (40 or more units of alcohol per week) or equivalent per week as assessed by diet questionnaires or changes to smoking habits
- Individuals who have participated in other intervention trials within 3 months prior to screening
- Allergies to components (soy) of the SmartBar (required for SmartPill protocol)
- Abdominal pain for less than 2 days in the screening week (based on the GSRS mild to severe)
- Those who report adequate relief of symptoms at baseline using the GSQ
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2020
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03803319
Start Date
January 2 2019
End Date
January 11 2020
Last Update
February 6 2020
Active Locations (1)
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1
King's College London
London, United Kingdom, SE1 9NH