Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)

NCT03803319 | Completed

• 1 other identifier: 18/WA/0313
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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).

Conditions

Irritable Bowel Syndrome

Keywords

dietary fibre

Outcome Measures

Primary Outcomes (2)

• 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

  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

  0, 4, 8 weeks

Secondary Outcomes (20)

• Whole gut and regional gut transit time as assessed using a telemetric device (wireless motility capsule: SmartPill)

  0 and 8 weeks

• Colonic pH units as assessed using a telemetric device (wireless motility capsule: SmartPill)

  0 and 8 weeks

• Pressure (mmHg) as assessed using a telemetric device (wireless motility capsule: SmartPill)

  0 and 8 weeks

• Faecal short-chain fatty acids (SCFAs) as assessed using gas-liquid chromatography

  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

  0, 4, 8 weeks

Other Outcomes (1)

• Visceral sensitivity as assessed using the Visceral Sensitivity Index (VSI) (6 point scale: strongly agree - strongly disagree)

  0 and 8 weeks

Study Arms (3)

Fibre 1 (combined fibres)

ACTIVE COMPARATOR

Ingestion of 150mls water with 7.5g fibre (two times a day)

Dietary Supplement: Fibre 1 (combined fibres)

Fibre 2 (natural fibres)

ACTIVE COMPARATOR

Ingestion of 150mls water with 15g fibre (two times a day)

Dietary Supplement: Fibre 2 (natural fibres)

Dietary Supplement (placebo)

PLACEBO COMPARATOR

Ingestion of 150mls water with 7.5g (two times a day)

Dietary Supplement: Dietary Supplement: placebo

Interventions

Fibre 1 (combined fibres) DIETARY_SUPPLEMENT

Dietary fibre supplement

Fibre 1 (combined fibres)

Fibre 2 (natural fibres) DIETARY_SUPPLEMENT

Dietary fibre supplement

Fibre 2 (natural fibres)

Dietary Supplement: placebo DIETARY_SUPPLEMENT

Dietary supplement

Dietary Supplement (placebo)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Universidad Veracruzana: collaborator
• University of Liverpool: collaborator

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Kevin C Whelan, PhD

  King's College London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and Investigators will be blinded to the fibre provided over the 8-week intervention period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multi-centre, 3 treatment, placebo-controlled trial

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 14, 2019
• Study Start: January 2, 2019
• Primary Completion: January 11, 2020
• Study Completion: January 11, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)