Irritable Bowel SyndromeNCT03803319
Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)
A study testing Fibre 1 (combined fibres) and Fibre 2 (natural fibres) in people with Irritable Bowel Syndrome, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Fibre 1 (combined fibres) and Fibre 2 (natural fibres)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2019to 11 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiological and Physiological Effects of Dietary Supplementation With Fibre in Irritable Bowel Syndrome: a Randomised Controlled Trial
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).
Read the 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).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Fibre 1 (combined fibres), Fibre 2 (natural fibres), Dietary Supplement: placebo
- Keywords
- dietary fibre
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibre 1 (combined fibres)Dietary supplement
Dietary fibre supplement
Fibre 2 (natural fibres)Dietary supplement
Dietary fibre supplement
Dietary Supplement: placeboDietary supplement
Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Fibre 1 (combined fibres) | Active comparator | Ingestion of 150mls water with 7.5g fibre (two times a day) Receives: Dietary Supplement: Fibre 1 (combined fibres) |
| Fibre 2 (natural fibres) | Active comparator | Ingestion of 150mls water with 15g fibre (two times a day) Receives: Dietary Supplement: Fibre 2 (natural fibres) |
| Dietary Supplement (placebo) | Placebo comparator | Ingestion of 150mls water with 7.5g (two times a day) Receives: Dietary Supplement: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0, 4, 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
Measured: 0, 4, 8 weeks
Secondary outcomes (20)
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
Measured: 0 and 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
Measured: 0 and 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
Measured: 0 and 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
Measured: 0, 4, 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
Measured: 0, 4, 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
Measured: 0 and 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
Measured: 0 and 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
Measured: 0 and 8 weeks
Serum/plasma metabolites as determined using metabolomics
Change from baseline in plasma/serum metabolites between the three groups at 8 weeks
Measured: 0 and 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
Measured: 0 and 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
Measured: 0 and 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
Measured: 0, 4, 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
Measured: 0, 4, 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
Measured: 0, 4, 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
Measured: 0, 4, 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
Measured: 8 weeks
Nutrient intake as assessed using a 7-day food diary
7-day food diary
Measured: 0 and 8 weeks
Physical activity as assessed using the International Physical Activity Questionnaire (IPAQ)
Physical activity
Measured: 0 weeks
Waist circumference as assessed using a standard measuring tape (inches)
Change from baseline in waist circumference between the three groups at 8 weeks
Measured: 0 and 8 weeks
Hydrogen/methane breath testing as assessed using the Gastrocheck Gastrolyzer V9.0 in parts per million
Hydrogen/methane breath testing
Measured: 0 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start2 Jan 2019
- Primary completion11 Jan 2020
- Study completion11 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multi-centre, 3 treatment, placebo-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Universidad Veracruzana, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Kevin C Whelan, PhD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803319
- Sponsor's protocol ID
- 18/WA/0313
- Status last verified
- Jan 2020
- First submitted
- 14 Dec 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant information will only be available to the Investigators undertaking the study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological and Physiological Effects of Dietary Supplementation With Fibre in Irritable Bowel Syndrome: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03803319
- Acronym / sponsor ID
- 18/WA/0313
- Conditions
- Irritable Bowel Syndrome
- Keywords
- dietary fibre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Universidad Veracruzana, University of Liverpool
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 11 Jan 2020 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- multi-centre, 3 treatment, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Fibre 1 (combined fibres) | Active comparator | Dietary Supplement: Fibre 1 (combined fibres)Ingestion of 150mls water with 7.5g fibre (two times a day) |
| Fibre 2 (natural fibres) | Active comparator | Dietary Supplement: Fibre 2 (natural fibres)Ingestion of 150mls water with 15g fibre (two times a day) |
| Dietary Supplement (placebo) | Placebo comparator | Dietary Supplement: Dietary Supplement: placeboIngestion of 150mls water with 7.5g (two times a day) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibre 1 (combined fibres)Dietary fibre supplement | Dietary supplement | Fibre 1 (combined fibres) |
| Fibre 2 (natural fibres)Dietary fibre supplement | Dietary supplement | Fibre 2 (natural fibres) |
| Dietary Supplement: placeboDietary supplement | Dietary supplement | Dietary Supplement (placebo) |
Primary outcome
Relative abundance of faecal bifidobacteria as assessed using 16S rRNA community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples
Time frame: 0, 4, 8 weeks
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)
Time frame: 0, 4, 8 weeks
Change from baseline in the GSQ between the three groups at 8 weeks
20 secondary outcomes
Whole gut and regional gut transit time as assessed using a telemetric device (wireless motility capsule: SmartPill)
Time frame: 0 and 8 weeks
Colonic pH units as assessed using a telemetric device (wireless motility capsule: SmartPill)
Time frame: 0 and 8 weeks
Pressure (mmHg) as assessed using a telemetric device (wireless motility capsule: SmartPill)
Time frame: 0 and 8 weeks
Faecal short-chain fatty acids (SCFAs) as assessed using gas-liquid chromatography
Time frame: 0, 4, 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
Time frame: 0, 4, 8 weeks
Faecal volatile organic compounds (VOCs) as assessed using gas chromatography sensor device
Time frame: 0 and 8 weeks
Serum/plasma appetite hormones (ghrelin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: 0 and 8 weeks
Serum/plasma (leptin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: 0 and 8 weeks
Serum/plasma metabolites as determined using metabolomics
Time frame: 0 and 8 weeks
Stool consistency as assessed using the Bristol Stool Form Scale (BSFS) (7 point scale; Type 1 to Type 7)
Time frame: 0 and 8 weeks
Gastrointestinal symptoms as assessed using the Gastrointestinal Symptom Rating Scale (GSRS) over 7 days (absent - severe)
Time frame: 0 and 8 weeks
Gastrointestinal symptoms as assessed using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) (visual analogue scale: no pain - severe)
Time frame: 0, 4, 8 weeks
Quality of Life (QoL) general as assessed using the SF-36
Time frame: 0, 4, 8 weeks
Disease-specific QoL as assessed using the IBS-QoL (5 point scale: not at all - a great deal)
Time frame: 0, 4, 8 weeks
Perceived stress as assessed using the Perceived Stress Score (PSS) (5 point scale: never- very often)
Time frame: 0, 4, 8 weeks
Dietary fibre acceptability as assessed using an acceptability questionnaire (5 point scale: not at all acceptable - extremely acceptable)
Time frame: 8 weeks
Nutrient intake as assessed using a 7-day food diary
Time frame: 0 and 8 weeks
Physical activity as assessed using the International Physical Activity Questionnaire (IPAQ)
Time frame: 0 weeks
Waist circumference as assessed using a standard measuring tape (inches)
Time frame: 0 and 8 weeks
Hydrogen/methane breath testing as assessed using the Gastrocheck Gastrolyzer V9.0 in parts per million
Time frame: 0 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No. Participant information will only be available to the Investigators undertaking the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin C Whelan, PhD study director
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibre 1 (combined fibres) and Fibre 2 (natural fibres) in people with Irritable Bowel Syndrome, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of faecal bifidobacteria as assessed using 16S rRNA community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples (time frame: 0, 4, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.