<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03803319</url>
  </required_header>
  <id_info>
    <org_study_id>18/WA/0313</org_study_id>
    <nct_id>NCT03803319</nct_id>
  </id_info>
  <brief_title>Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)</brief_title>
  <official_title>Microbiological and Physiological Effects of Dietary Supplementation With Fibre in Irritable Bowel Syndrome: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Veracruzana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate how different dietary fibre combinations affects&#xD;
      physiological and microbiological outcomes, in addition to symptoms in those with IBS. The&#xD;
      study will also explore the differences in responses between different fibres in different&#xD;
      sub-types of IBS (e.g. constipation-predominant, diarrhoea-predominant and mixed).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, national and international guidelines are based upon trials of dietary fibre in&#xD;
      IBS symptoms that report opposing effects. For this reason, recommendations regarding dietary&#xD;
      fibre food supplementation in IBS are often conflicting. Indeed, the confusion surrounding&#xD;
      dietary fibre recommendations in IBS is a consequence of the limited understanding of the&#xD;
      different types of dietary fibres used, their physiology and their functions in different&#xD;
      sub-groups of IBS.&#xD;
&#xD;
      Different fibres have different characteristics (e.g. solubility, viscosity and&#xD;
      fermentability) which drive different functionalities (stool forming, fermentation) in the&#xD;
      gastrointestinal tract, yet it is currently unknown whether administration of dietary fibre&#xD;
      combinations will result in symptomatic improvement in people with IBS.&#xD;
&#xD;
      Participants will be randomised to one of three parallel arms for a duration of 8 weeks.&#xD;
&#xD;
      The study will consist of 4 visits in total. The first visit will involve taking consent and&#xD;
      assessing eligibility. Participants will complete the Rome IV diagnostic criteria as part of&#xD;
      their eligibility assessment. Participants will be asked to complete a food and symptom diary&#xD;
      for the next 7 days. Diary data will be used to confirm frequency and severity of IBS&#xD;
      symptoms and ensure there is no discrepancy between participant report on the Rome IV&#xD;
      diagnostic criteria.&#xD;
&#xD;
      Visit 2: Baseline (approx 1.5 hours). Height and weight will be recorded. Participants will&#xD;
      complete 7 questionnaires, provide a stool sample, a blood sample and will ingest the&#xD;
      SmartPill (wireless motility capsule). Participants will blinded to the intervention and will&#xD;
      be provided with sachets containing either fibre 1 (combined fibres), fibre 2 (natural&#xD;
      fibres) or placebo to consume over an 8-week period.&#xD;
&#xD;
      Visit 3: Mid-point (approx 1 hour). Participants will complete 5 questionnaires and provide a&#xD;
      stool sample.&#xD;
&#xD;
      Visit 4: Endpoint (approx 1.5 hours). Height and weight will be recorded. Participants will&#xD;
      complete 7 questionnaires, provide a stool sample, a blood sample and will ingest the&#xD;
      SmartPill (wireless motility capsule).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">January 11, 2020</completion_date>
  <primary_completion_date type="Actual">January 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>multi-centre, 3 treatment, placebo-controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants and Investigators will be blinded to the fibre provided over the 8-week intervention period.</masking_description>
  </study_design_info>
  <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</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Change from baseline in relative abundance of bifidobacteria between the three groups at 8 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IBS symptoms as assessed using the Global Symptom Question (GSQ)</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Change from baseline in the GSQ between the three groups at 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Whole gut and regional gut transit time as assessed using a telemetric device (wireless motility capsule: SmartPill)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in whole and regional gut transit time between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colonic pH units as assessed using a telemetric device (wireless motility capsule: SmartPill)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in colonic pH units between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure (mmHg) as assessed using a telemetric device (wireless motility capsule: SmartPill)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in pressure (mmHg) between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faecal short-chain fatty acids (SCFAs) as assessed using gas-liquid chromatography</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Change from baseline in microbial metabolites between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faecal gut microbiota (α and β diversity) as assessed using 16S rRNA community profiling (Illumina Miseq) of bacterial genomic DNA isolated from stool samples</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Change from baseline in faecal gut microbiota (α and β diversity) between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faecal volatile organic compounds (VOCs) as assessed using gas chromatography sensor device</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in VOCs between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum/plasma appetite hormones (ghrelin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in ghrelin concentrations between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum/plasma (leptin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in leptin concentrations between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum/plasma metabolites as determined using metabolomics</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in plasma/serum metabolites between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool consistency as assessed using the Bristol Stool Form Scale (BSFS) (7 point scale; Type 1 to Type 7)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in stool consistency and stool frequency between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms as assessed using the Gastrointestinal Symptom Rating Scale (GSRS) over 7 days (absent - severe)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in gastrointestinal symptoms between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms as assessed using the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) (visual analogue scale: no pain - severe)</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Change from baseline in the severity of gastrointestinal symptoms between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) general as assessed using the SF-36</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Change from baseline in general QoL between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific QoL as assessed using the IBS-QoL (5 point scale: not at all - a great deal)</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Change from baseline in disease-specific QoL between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress as assessed using the Perceived Stress Score (PSS) (5 point scale: never- very often)</measure>
    <time_frame>0, 4, 8 weeks</time_frame>
    <description>Change from baseline in perceived stress between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary fibre acceptability as assessed using an acceptability questionnaire (5 point scale: not at all acceptable - extremely acceptable)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Dietary fibre acceptability between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrient intake as assessed using a 7-day food diary</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>7-day food diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity as assessed using the International Physical Activity Questionnaire (IPAQ)</measure>
    <time_frame>0 weeks</time_frame>
    <description>Physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference as assessed using a standard measuring tape (inches)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in waist circumference between the three groups at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hydrogen/methane breath testing as assessed using the Gastrocheck Gastrolyzer V9.0 in parts per million</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Hydrogen/methane breath testing</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Visceral sensitivity as assessed using the Visceral Sensitivity Index (VSI) (6 point scale: strongly agree - strongly disagree)</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Change from baseline in visceral sensitivity between the three groups at 8 weeks</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Fibre 1 (combined fibres)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ingestion of 150mls water with 7.5g fibre (two times a day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fibre 2 (natural fibres)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ingestion of 150mls water with 15g fibre (two times a day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dietary Supplement (placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ingestion of 150mls water with 7.5g (two times a day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fibre 1 (combined fibres)</intervention_name>
    <description>Dietary fibre supplement</description>
    <arm_group_label>Fibre 1 (combined fibres)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Fibre 2 (natural fibres)</intervention_name>
    <description>Dietary fibre supplement</description>
    <arm_group_label>Fibre 2 (natural fibres)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary Supplement: placebo</intervention_name>
    <description>Dietary supplement</description>
    <arm_group_label>Dietary Supplement (placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Interested in taking part&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Men and women aged 18-65 years with diarrhoea-predominant IBS (IBS-D),&#xD;
             constipation-dominant IBS (IBS-C), or mixed (IBS-M), based on fulfilment of the Rome&#xD;
             IV criteria for irritable bowel syndrome who do not have a major medical condition&#xD;
             (e.g. diabetes, psychiatric or current eating disorders), severe oesophagitis,&#xD;
             gastritis or duodenitis, gastrointestinal disease (inflammatory bowel disease, coeliac&#xD;
             disease, active diverticulitis), or history of previous GI surgery (excluding&#xD;
             appendicectomy, cholecystectomy and haemorrhoidectomy), severe renal, cardiac,&#xD;
             pulmonary, or other chronic diseases likely to affect motility, history of gastric&#xD;
             bezoars.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females who report to be pregnant or lactating&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;40 kg/m2&#xD;
&#xD;
          -  Use of unpermitted medications in the last 4 weeks prior to, or during the study&#xD;
             including: Antibiotics within the last 4weeks, dietary fibre food supplements within&#xD;
             the last 4 weeks (e.g. Fybogel, Lactulose), prebiotics or probiotics (in food products&#xD;
             or as supplements) within the last 4 weeks, other dietary supplements that may affect&#xD;
             the luminal microenvironment of the intestine (e.g. Orlistat)&#xD;
&#xD;
          -  Use of drugs known to alter GI motility, transit or gastric pH (e.g. mebeverine,&#xD;
             opiates, monoamine oxidase inhibitors, phenothiazines) in the last 1 week&#xD;
&#xD;
          -  Full bowel preparation for a diagnostic procedure within the last 4 weeks&#xD;
&#xD;
          -  Changes to IBS medications or dose in the 4 weeks prior to the study&#xD;
&#xD;
          -  Changes to anti-depressant medications or dose in the 12 weeks prior to the study&#xD;
&#xD;
          -  Swallowing disorders (physical or psychological)&#xD;
&#xD;
          -  Use of implantable and/or medical devices such as pacemakers&#xD;
&#xD;
          -  Individuals following extreme diets e.g. 8 or more caffeinated serves per day, 4 or&#xD;
             more bottles of wine (40 or more units of alcohol per week) or equivalent per week as&#xD;
             assessed by diet questionnaires or changes to smoking habits&#xD;
&#xD;
          -  Individuals who have participated in other intervention trials within 3 months prior&#xD;
             to screening&#xD;
&#xD;
          -  Allergies to components (soy) of the SmartBar (required for SmartPill protocol)&#xD;
&#xD;
          -  Abdominal pain for less than 2 days in the screening week (based on the GSRS mild to&#xD;
             severe)&#xD;
&#xD;
          -  Those who report adequate relief of symptoms at baseline using the GSQ&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin C Whelan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE1 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dietary fibre</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participant information will only be available to the Investigators undertaking the study.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03803319
org study id: 18/WA/0313
nct id: NCT03803319
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: multi-centre, 3 treatment, placebo-controlled trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Participants and Investigators will be blinded to the fibre provided over the 8-week intervention period.
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
description: Change from baseline in relative abundance of bifidobacteria between the three groups at 8 weeks
measure: IBS symptoms as assessed using the Global Symptom Question (GSQ)
time frame: 0, 4, 8 weeks
description: Change from baseline in the GSQ between the three groups at 8 weeks
measure: Whole gut and regional gut transit time as assessed using a telemetric device (wireless motility capsule: SmartPill)
time frame: 0 and 8 weeks
description: Change from baseline in whole and regional gut transit time between the three groups at 8 weeks
measure: Colonic pH units as assessed using a telemetric device (wireless motility capsule: SmartPill)
time frame: 0 and 8 weeks
description: Change from baseline in colonic pH units between the three groups at 8 weeks
measure: Pressure (mmHg) as assessed using a telemetric device (wireless motility capsule: SmartPill)
time frame: 0 and 8 weeks
description: Change from baseline in pressure (mmHg) between the three groups at 8 weeks
measure: Faecal short-chain fatty acids (SCFAs) as assessed using gas-liquid chromatography
time frame: 0, 4, 8 weeks
description: Change from baseline in microbial metabolites between the three groups at 8 weeks
measure: 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
description: Change from baseline in faecal gut microbiota (α and β diversity) between the three groups at 8 weeks
measure: Faecal volatile organic compounds (VOCs) as assessed using gas chromatography sensor device
time frame: 0 and 8 weeks
description: Change from baseline in VOCs between the three groups at 8 weeks
measure: Serum/plasma appetite hormones (ghrelin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)
time frame: 0 and 8 weeks
description: Change from baseline in ghrelin concentrations between the three groups at 8 weeks
measure: Serum/plasma (leptin, pg/ml) as determined by enzyme-linked immunosorbent assay (ELISA)
time frame: 0 and 8 weeks
description: Change from baseline in leptin concentrations between the three groups at 8 weeks
measure: Serum/plasma metabolites as determined using metabolomics
time frame: 0 and 8 weeks
description: Change from baseline in plasma/serum metabolites between the three groups at 8 weeks
measure: 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
description: Change from baseline in stool consistency and stool frequency between the three groups at 8 weeks
measure: Gastrointestinal symptoms as assessed using the Gastrointestinal Symptom Rating Scale (GSRS) over 7 days (absent - severe)
time frame: 0 and 8 weeks
description: Change from baseline in gastrointestinal symptoms between the three groups at 8 weeks
measure: 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
description: Change from baseline in the severity of gastrointestinal symptoms between the three groups at 8 weeks
measure: Quality of Life (QoL) general as assessed using the SF-36
time frame: 0, 4, 8 weeks
description: Change from baseline in general QoL between the three groups at 8 weeks
measure: Disease-specific QoL as assessed using the IBS-QoL (5 point scale: not at all - a great deal)
time frame: 0, 4, 8 weeks
description: Change from baseline in disease-specific QoL between the three groups at 8 weeks
measure: Perceived stress as assessed using the Perceived Stress Score (PSS) (5 point scale: never- very often)
time frame: 0, 4, 8 weeks
description: Change from baseline in perceived stress between the three groups at 8 weeks
measure: Dietary fibre acceptability as assessed using an acceptability questionnaire (5 point scale: not at all acceptable - extremely acceptable)
time frame: 8 weeks
description: Dietary fibre acceptability between the three groups at 8 weeks
measure: Nutrient intake as assessed using a 7-day food diary
time frame: 0 and 8 weeks
description: 7-day food diary
measure: Physical activity as assessed using the International Physical Activity Questionnaire (IPAQ)
time frame: 0 weeks
description: Physical activity
measure: Waist circumference as assessed using a standard measuring tape (inches)
time frame: 0 and 8 weeks
description: Change from baseline in waist circumference between the three groups at 8 weeks
measure: Hydrogen/methane breath testing as assessed using the Gastrocheck Gastrolyzer V9.0 in parts per million
time frame: 0 and 8 weeks
description: Hydrogen/methane breath testing
measure: Visceral sensitivity as assessed using the Visceral Sensitivity Index (VSI) (6 point scale: strongly agree - strongly disagree)
time frame: 0 and 8 weeks
description: Change from baseline in visceral sensitivity between the three groups at 8 weeks
arm group label: Fibre 1 (combined fibres)
arm group type: Active Comparator
description: Ingestion of 150mls water with 7.5g fibre (two times a day)
arm group label: Fibre 2 (natural fibres)
arm group type: Active Comparator
description: Ingestion of 150mls water with 15g fibre (two times a day)
arm group label: Dietary Supplement (placebo)
arm group type: Placebo Comparator
description: Ingestion of 150mls water with 7.5g (two times a day)
intervention type: Dietary Supplement
intervention name: Fibre 1 (combined fibres)
description: Dietary fibre supplement
arm group label: Fibre 1 (combined fibres)
intervention type: Dietary Supplement
intervention name: Fibre 2 (natural fibres)
description: Dietary fibre supplement
arm group label: Fibre 2 (natural fibres)
intervention type: Dietary Supplement
intervention name: Dietary Supplement: placebo
description: Dietary supplement
arm group label: Dietary Supplement (placebo)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kevin C Whelan, PhD
role: Study Director
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
sharing ipd: No
ipd description: Participant information will only be available to the Investigators undertaking the study.