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Fibre and Gas in Irritable Bowel Syndrome (EFIGI)

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ClinicalTrials.gov Identifier: NCT03265002
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

The aim of the study is to investigate how dietary fibre combinations affects gut physiology, particularly colonic gas production. Comparisons will be made between a single fermentable fibre (inulin), a non-fermentable fibre (psyllium) and a combination of the two. The study will also explore differences in response between diarrhoea-predominant and constipation-predominant IBS (IBS-D and IBS-C) respectively.

The participants will have a preliminary meeting to ensure they are eligible, then will attend the MRI department on 4 occasions separated by at least 1 week. They will ingest a drink with the fibre product mixed in, and will have 8 MRI scans (each lasting approximately 15 minutes).


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Placebo Dietary Supplement: Inulin Dietary Supplement: Psyllium Dietary Supplement: Inulin and psyllium Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: single-centre, 4 period, 4 treatment, placebo-controlled crossover trial.
Masking: Double (Participant, Investigator)
Masking Description:

Participants will be blind to the fibre product taken on each study visit. Masking will be assisted by adding lemon juice to the vehicle drink.

The staff responsible for preparing this food will be members of the digestive diseases unit at the NIHR Nottingham Biomedical Research Centre and will not be involved in the study otherwise. The investigators responsible for MRI and symptom analysis will be kept blind to the intervention as data will be coded by date of study day, rather than by product received. Additionally MRI data will be assigned a 'scanning number' through the Sir Peter Mansfield Imaging Centre. This will pseudo-anonymise MRI data within the study so that associations between participants and scans will not be immediately obvious.

Primary Purpose: Basic Science
Official Title: Effects of Fibre on Intestinal Volume and Gas in Irritable Bowel Syndrome
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Placebo Comparator: Placebo
Ingestion of 500ml water with 50ml lemon juice and 20g dextrose
Dietary Supplement: Placebo
Ingestion of 500ml water with 50ml lemon juice and 20g dextrose

Experimental: Inulin
Ingestion of 500ml water with 50ml lemon juice and 20g inulin
Dietary Supplement: Inulin
Ingestion of 500ml water with 50ml lemon juice and 20g inulin

Active Comparator: Psyllium
Ingestion of 500ml water with 50ml lemon juice and 20g psyllium
Dietary Supplement: Psyllium
Ingestion of 500ml water with 50ml lemon juice and 20g psyllium

Active Comparator: Inulin and Psyllium
Ingestion of 500ml water with 50ml lemon juice and 20g inulin and 20g psyllium
Dietary Supplement: Inulin and psyllium
Ingestion of 500ml water with 50ml lemon juice and 20g inulin and 20g psyllium




Primary Outcome Measures :
  1. Change from the baseline in colonic gas [ Time Frame: baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink ]
    in arbitrary units measured by MRI


Secondary Outcome Measures :
  1. Change from the baseline in colonic volume [ Time Frame: baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink ]
    in mL measured by MRI

  2. Change from the baseline in small bowel water content [ Time Frame: baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink ]
    in mL measured by MRI

  3. Change from the baseline in breath hydrogen [ Time Frame: baseline, 0mins, 30mins, 1 hour, 90mins, 2 hours, 3, 4, 5 and 6 hours post ingestion of fibre drink ]
    in parts per million using the GastroCheck device

  4. Change from the baseline in severity of pain, bloating and flatulence [ Time Frame: baseline, 0mins, 30mins, 1 hour, 90mins, 2 hours, 3, 4, 5 and 6 hours post ingestion of fibre drink ]
    assessed by the Gastrointestinal Symptom Rating Scale, using a 7-point scale


Other Outcome Measures:
  1. Product acceptability [ Time Frame: throughout the study completion, measured after the 6 hour postprandial measurements. ]
    gained by questionnaire

  2. Change from the baseline in contractility of the ascending colon [ Time Frame: baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink ]
    assessed by the MRI motility index

  3. breath methane [ Time Frame: baseline, 0mins, 30mins, 1 hour, 90mins, 2 hours, 3, 4, 5 and 6 hours post ingestion of fibre drink ]
    in parts per million using the GastroCheck device



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to give informed consent
  • Fulfilment of the Rome IV criteria for Irritable Bowel Syndrome for at least 3 months:

    • Abdominal pain at least two or more days per week.
    • Pain associated with two or more of the following:

      • Related to defecation on at least ≥30% of occasions
      • Associated with a change in frequency of stool on ≥30% of occasions
      • Associated with a change in form (appearance) of stool on ≥30% of occasions
    • Symptom onset at least 6 months prior to diagnosis

Exclusion Criteria:

  • Pregnancy declared by candidate
  • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
  • Inability to lie flat or exceed scanner limits of weight <120kg
  • Unwilling to cease use of supplementary fibre or osmotic laxatives for the duration of the study
  • Unable to stop drugs known to alter GI motility or transit including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists or osmotic laxatives for 2 days before, and during, MRI study days.

    • Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria
  • Reported alcohol intake of >28 units/ week with daily drinking
  • Intention to change smoking behaviour during the study
  • History declared by the candidate of other pre-existing gastrointestinal disorders, including but not limited to:

    • Inflammatory Bowel Disease
    • Coeliac Disease
    • Pancreatitis
    • Gallstone disease (biliary colic, cholecystitis; asymptomatic presence of gallstones permitted)
    • Complicated diverticulitis (asymptomatic presence of diverticula permitted)
    • Cancer of the gastrointestinal tract
    • Gastroparesis
    • Other functional gastrointestinal disorders will be permitted as they frequently co-exist with IBS.
  • Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy)
  • Presence of an intestinal stoma
  • Poor understanding of English language
  • Participation of any medical trials for the past 3 months
  • Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe COPD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265002


Contacts
Contact: David Gunn, BMBS 01158231073 david.gunn@nottingham.ac.uk
Contact: Giles Major, PhD, BMBS giles.major@nottingham.ac.uk

Locations
United Kingdom
University of Nottingham Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Contact: David Gunn, BMBS    01159709966    david.gunn@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
Study Chair: Robin Spiller, Ph, BMBS University of Nottingham

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03265002     History of Changes
Other Study ID Numbers: 17056
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Nottingham:
fibre
inulin
psyllium
small bowel MRI

Additional relevant MeSH terms:
Colonic Diseases, Functional
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals