Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)
NCT ID: NCT03803319
Last Updated: 2020-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2019-01-02
2020-01-11
Brief Summary
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Detailed Description
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Different fibres have different characteristics (e.g. solubility, viscosity and fermentability) which drive different functionalities (stool forming, fermentation) in the gastrointestinal tract, yet it is currently unknown whether administration of dietary fibre combinations will result in symptomatic improvement in people with IBS.
Participants will be randomised to one of three parallel arms for a duration of 8 weeks.
The study will consist of 4 visits in total. The first visit will involve taking consent and assessing eligibility. Participants will complete the Rome IV diagnostic criteria as part of their eligibility assessment. Participants will be asked to complete a food and symptom diary for the next 7 days. Diary data will be used to confirm frequency and severity of IBS symptoms and ensure there is no discrepancy between participant report on the Rome IV diagnostic criteria.
Visit 2: Baseline (approx 1.5 hours). Height and weight will be recorded. Participants will complete 7 questionnaires, provide a stool sample, a blood sample and will ingest the SmartPill (wireless motility capsule). Participants will blinded to the intervention and will be provided with sachets containing either fibre 1 (combined fibres), fibre 2 (natural fibres) or placebo to consume over an 8-week period.
Visit 3: Mid-point (approx 1 hour). Participants will complete 5 questionnaires and provide a stool sample.
Visit 4: Endpoint (approx 1.5 hours). Height and weight will be recorded. Participants will complete 7 questionnaires, provide a stool sample, a blood sample and will ingest the SmartPill (wireless motility capsule).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fibre 1 (combined fibres)
Ingestion of 150mls water with 7.5g fibre (two times a day)
Fibre 1 (combined fibres)
Dietary fibre supplement
Fibre 2 (natural fibres)
Ingestion of 150mls water with 15g fibre (two times a day)
Fibre 2 (natural fibres)
Dietary fibre supplement
Dietary Supplement (placebo)
Ingestion of 150mls water with 7.5g (two times a day)
Dietary Supplement: placebo
Dietary supplement
Interventions
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Fibre 1 (combined fibres)
Dietary fibre supplement
Fibre 2 (natural fibres)
Dietary fibre supplement
Dietary Supplement: placebo
Dietary supplement
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Universidad Veracruzana
OTHER
University of Liverpool
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Kevin C Whelan, PhD
Role: STUDY_DIRECTOR
King's College London
Locations
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King's College London
London, , United Kingdom
Countries
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Other Identifiers
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18/WA/0313
Identifier Type: -
Identifier Source: org_study_id
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