Back to resultsEffects of Dietary Fibre in Irritable Bowel Syndrome (IBS)
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fibre 1 (combined fibres)
Fibre 2 (natural fibres)
Dietary Supplement: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring dietary fibre
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Fibre 1 (combined fibres)
Fibre 2 (natural fibres)
Dietary Supplement (placebo)
Arm Description
Ingestion of 150mls water with 7.5g fibre (two times a day)
Ingestion of 150mls water with 15g fibre (two times a day)
Ingestion of 150mls water with 7.5g (two times a day)
Outcomes
Primary Outcome Measures
Relative abundance of faecal bifidobacteria as assessed using 16S rRNA community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples
Change from baseline in relative abundance of bifidobacteria between the three groups at 8 weeks
IBS symptoms as assessed using the Global Symptom Question (GSQ)
Change from baseline in the GSQ between the three groups at 8 weeks
Secondary Outcome Measures
Whole gut and regional gut transit time as assessed using a telemetric device (wireless motility capsule: SmartPill)
Change from baseline in whole and regional gut transit time between the three groups at 8 weeks
Colonic pH units as assessed using a telemetric device (wireless motility capsule: SmartPill)
Change from baseline in colonic pH units between the three groups at 8 weeks
Pressure (mmHg) as assessed using a telemetric device (wireless motility capsule: SmartPill)
Change from baseline in pressure (mmHg) between the three groups at 8 weeks
Faecal short-chain fatty acids (SCFAs) as assessed using gas-liquid chromatography
Change from baseline in microbial metabolites between the three groups at 8 weeks
Faecal gut microbiota (α and β diversity) as assessed using 16S rRNA community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples
Change from baseline in faecal gut microbiota (α and β diversity) between the three groups at 8 weeks
Faecal volatile organic compounds (VOCs) as assessed using gas chromatography sensor device
Change from baseline in VOCs between the three groups at 8 weeks
Serum/plasma appetite hormones (ghrelin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)
Change from baseline in ghrelin concentrations between the three groups at 8 weeks
Serum/plasma (leptin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)
Change from baseline in leptin concentrations between the three groups at 8 weeks
Serum/plasma metabolites as determined using metabolomics
Change from baseline in plasma/serum metabolites between the three groups at 8 weeks
Stool consistency as assessed using the Bristol Stool Form Scale (BSFS) (7 point scale; Type 1 to Type 7)
Change from baseline in stool consistency and stool frequency between the three groups at 8 weeks
Gastrointestinal symptoms as assessed using the Gastrointestinal Symptom Rating Scale (GSRS) over 7 days (absent - severe)
Change from baseline in gastrointestinal symptoms between the three groups at 8 weeks
Gastrointestinal symptoms as assessed using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) (visual analogue scale: no pain - severe)
Change from baseline in the severity of gastrointestinal symptoms between the three groups at 8 weeks
Quality of Life (QoL) general as assessed using the SF-36
Change from baseline in general QoL between the three groups at 8 weeks
Disease-specific QoL as assessed using the IBS-QoL (5 point scale: not at all - a great deal)
Change from baseline in disease-specific QoL between the three groups at 8 weeks
Perceived stress as assessed using the Perceived Stress Score (PSS) (5 point scale: never- very often)
Change from baseline in perceived stress between the three groups at 8 weeks
Dietary fibre acceptability as assessed using an acceptability questionnaire (5 point scale: not at all acceptable - extremely acceptable)
Dietary fibre acceptability between the three groups at 8 weeks
Nutrient intake as assessed using a 7-day food diary
7-day food diary
Physical activity as assessed using the International Physical Activity Questionnaire (IPAQ)
Physical activity
Waist circumference as assessed using a standard measuring tape (inches)
Change from baseline in waist circumference between the three groups at 8 weeks
Hydrogen/methane breath testing as assessed using the Gastrocheck Gastrolyzer V9.0 in parts per million
Hydrogen/methane breath testing
Full Information
NCT ID
NCT03803319
First Posted
December 14, 2018
Last Updated
February 5, 2020
Sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust, Universidad Veracruzana, University of Liverpool
1. Study Identification
Unique Protocol Identification Number
NCT03803319
Brief Title
Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)
Official Title
Microbiological and Physiological Effects of Dietary Supplementation With Fibre in Irritable Bowel Syndrome: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
January 11, 2020 (Actual)
Study Completion Date
January 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust, Universidad Veracruzana, University of Liverpool
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 explore the differences in responses between different fibres in different sub-types of IBS (e.g. constipation-predominant, diarrhoea-predominant and mixed).
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 supplementation in IBS are often conflicting. Indeed, the confusion surrounding dietary fibre recommendations in IBS is a consequence of the limited understanding of the different types of dietary fibres used, their physiology and their functions in different sub-groups of IBS.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
dietary fibre
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multi-centre, 3 treatment, placebo-controlled trial
Masking
ParticipantInvestigator
Masking Description
Participants and Investigators will be blinded to the fibre provided over the 8-week intervention period.
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fibre 1 (combined fibres)
Arm Type
Active Comparator
Arm Description
Ingestion of 150mls water with 7.5g fibre (two times a day)
Arm Title
Fibre 2 (natural fibres)
Arm Type
Active Comparator
Arm Description
Ingestion of 150mls water with 15g fibre (two times a day)
Arm Title
Dietary Supplement (placebo)
Arm Type
Placebo Comparator
Arm Description
Ingestion of 150mls water with 7.5g (two times a day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Fibre 1 (combined fibres)
Intervention Description
Dietary fibre supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Fibre 2 (natural fibres)
Intervention Description
Dietary fibre supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: placebo
Intervention Description
Dietary supplement
Primary Outcome Measure Information:
Title
Relative abundance of faecal bifidobacteria as assessed using 16S rRNA community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples
Description
Change from baseline in relative abundance of bifidobacteria between the three groups at 8 weeks
Time Frame
0, 4, 8 weeks
Title
IBS symptoms as assessed using the Global Symptom Question (GSQ)
Description
Change from baseline in the GSQ between the three groups at 8 weeks
Time Frame
0, 4, 8 weeks
Secondary Outcome Measure Information:
Title
Whole gut and regional gut transit time as assessed using a telemetric device (wireless motility capsule: SmartPill)
Description
Change from baseline in whole and regional gut transit time between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Colonic pH units as assessed using a telemetric device (wireless motility capsule: SmartPill)
Description
Change from baseline in colonic pH units between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Pressure (mmHg) as assessed using a telemetric device (wireless motility capsule: SmartPill)
Description
Change from baseline in pressure (mmHg) between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Faecal short-chain fatty acids (SCFAs) as assessed using gas-liquid chromatography
Description
Change from baseline in microbial metabolites between the three groups at 8 weeks
Time Frame
0, 4, 8 weeks
Title
Faecal gut microbiota (α and β diversity) as assessed using 16S rRNA community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples
Description
Change from baseline in faecal gut microbiota (α and β diversity) between the three groups at 8 weeks
Time Frame
0, 4, 8 weeks
Title
Faecal volatile organic compounds (VOCs) as assessed using gas chromatography sensor device
Description
Change from baseline in VOCs between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Serum/plasma appetite hormones (ghrelin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)
Description
Change from baseline in ghrelin concentrations between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Serum/plasma (leptin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)
Description
Change from baseline in leptin concentrations between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Serum/plasma metabolites as determined using metabolomics
Description
Change from baseline in plasma/serum metabolites between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Stool consistency as assessed using the Bristol Stool Form Scale (BSFS) (7 point scale; Type 1 to Type 7)
Description
Change from baseline in stool consistency and stool frequency between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Gastrointestinal symptoms as assessed using the Gastrointestinal Symptom Rating Scale (GSRS) over 7 days (absent - severe)
Description
Change from baseline in gastrointestinal symptoms between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Gastrointestinal symptoms as assessed using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) (visual analogue scale: no pain - severe)
Description
Change from baseline in the severity of gastrointestinal symptoms between the three groups at 8 weeks
Time Frame
0, 4, 8 weeks
Title
Quality of Life (QoL) general as assessed using the SF-36
Description
Change from baseline in general QoL between the three groups at 8 weeks
Time Frame
0, 4, 8 weeks
Title
Disease-specific QoL as assessed using the IBS-QoL (5 point scale: not at all - a great deal)
Description
Change from baseline in disease-specific QoL between the three groups at 8 weeks
Time Frame
0, 4, 8 weeks
Title
Perceived stress as assessed using the Perceived Stress Score (PSS) (5 point scale: never- very often)
Description
Change from baseline in perceived stress between the three groups at 8 weeks
Time Frame
0, 4, 8 weeks
Title
Dietary fibre acceptability as assessed using an acceptability questionnaire (5 point scale: not at all acceptable - extremely acceptable)
Description
Dietary fibre acceptability between the three groups at 8 weeks
Time Frame
8 weeks
Title
Nutrient intake as assessed using a 7-day food diary
Description
7-day food diary
Time Frame
0 and 8 weeks
Title
Physical activity as assessed using the International Physical Activity Questionnaire (IPAQ)
Description
Physical activity
Time Frame
0 weeks
Title
Waist circumference as assessed using a standard measuring tape (inches)
Description
Change from baseline in waist circumference between the three groups at 8 weeks
Time Frame
0 and 8 weeks
Title
Hydrogen/methane breath testing as assessed using the Gastrocheck Gastrolyzer V9.0 in parts per million
Description
Hydrogen/methane breath testing
Time Frame
0 and 8 weeks
Other Pre-specified Outcome Measures:
Title
Visceral sensitivity as assessed using the Visceral Sensitivity Index (VSI) (6 point scale: strongly agree - strongly disagree)
Description
Change from baseline in visceral sensitivity between the three groups at 8 weeks
Time Frame
0 and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin C Whelan, PhD
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
King's College London
City
London
ZIP/Postal Code
SE1 9NH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Participant information will only be available to the Investigators undertaking the study.
Learn more about this trial
Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)
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