Fibre and Gas in Irritable Bowel Syndrome

NCT03265002 | Completed

• 1 other identifier: 17056
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Irritable Bowel Syndrome

Keywords

fibre; inulin; psyllium; small bowel MRI

Outcome Measures

Primary Outcomes (1)

• Change from the baseline in colonic gas

  in arbitrary units measured by MRI

  baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink

Secondary Outcomes (4)

• Change from the baseline in colonic volume

  baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink

• Change from the baseline in small bowel water content

  baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink

• Change from the baseline in breath hydrogen

  baseline, 0mins, 30mins, 1 hour, 90mins, 2 hours, 3, 4, 5 and 6 hours post ingestion of fibre drink

• Change from the baseline in severity of pain, bloating and flatulence

  baseline, 0mins, 30mins, 1 hour, 90mins, 2 hours, 3, 4, 5 and 6 hours post ingestion of fibre drink

Other Outcomes (3)

• Product acceptability

  throughout the study completion, measured after the 6 hour postprandial measurements.

• Change from the baseline in contractility of the ascending colon

  baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink

• breath methane

  baseline, 0mins, 30mins, 1 hour, 90mins, 2 hours, 3, 4, 5 and 6 hours post ingestion of fibre drink

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Ingestion of 500ml water with 50ml lemon juice and 20g dextrose

Dietary Supplement: Placebo

Inulin

EXPERIMENTAL

Ingestion of 500ml water with 50ml lemon juice and 20g inulin

Dietary Supplement: Inulin

Psyllium

ACTIVE COMPARATOR

Ingestion of 500ml water with 50ml lemon juice and 20g psyllium

Dietary Supplement: Psyllium

Inulin and Psyllium

ACTIVE COMPARATOR

Ingestion of 500ml water with 50ml lemon juice and 20g inulin and 20g psyllium

Dietary Supplement: Inulin and psyllium

Interventions

Placebo DIETARY_SUPPLEMENT

Ingestion of 500ml water with 50ml lemon juice and 20g dextrose

Placebo

Inulin DIETARY_SUPPLEMENT

Ingestion of 500ml water with 50ml lemon juice and 20g inulin

Inulin

Psyllium DIETARY_SUPPLEMENT

Ingestion of 500ml water with 50ml lemon juice and 20g psyllium

Psyllium

Inulin and psyllium DIETARY_SUPPLEMENT

Ingestion of 500ml water with 50ml lemon juice and 20g inulin and 20g psyllium

Inulin and Psyllium

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (2)

• Major G, Pritchard S, Murray K, Alappadan JP, Hoad CL, Marciani L, Gowland P, Spiller R. Colon Hypersensitivity to Distension, Rather Than Excessive Gas Production, Produces Carbohydrate-Related Symptoms in Individuals With Irritable Bowel Syndrome. Gastroenterology. 2017 Jan;152(1):124-133.e2. doi: 10.1053/j.gastro.2016.09.062. Epub 2016 Oct 14.

  PMID: 27746233 BACKGROUND

• Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.

  PMID: 34353864 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Inulin; Psyllium

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Robin Spiller, Ph, BMBS

  University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-centre, 4 period, 4 treatment, placebo-controlled crossover trial.

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 29, 2017
• Study Start: March 8, 2018
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)