Effects of Dietary Fibre in Irritable Bowel Syndrome (IBS)

Status Completed

Clinical 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. constipation-predominant, diarrhoea-predominant and mixed).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03803319
Study type	Interventional
Source	King's College London
Contact
Status	Completed
Phase	N/A
Start date	January 2, 2019
Completion date	January 11, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03720314` - Microbiota Profiling in IBS
Recruiting	`NCT06166563` - Exercise, Irritable Bowel Syndrome and Fibromyalgia	N/A
Completed	`NCT05213910` - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains	N/A
Recruiting	`NCT05985018` - Traditional Dietary Advice Vs. Mediterranean Diet in IBS	N/A
Completed	`NCT04486469` - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.	N/A
Completed	`NCT06407609` - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS	N/A
Completed	`NCT04656730` - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas	Phase 4
Completed	`NCT04145856` - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico	Phase 4
Recruiting	`NCT04138225` - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting	`NCT03586622` - One Year Home Monitoring and Treatment of IBS Patients	N/A
Completed	`NCT05207618` - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant	N/A
Not yet recruiting	`NCT06369753` - Visible Abdominal Distension	N/A
Not yet recruiting	`NCT05157867` - In Vivo Effects of Amylase Trypsin Inhibitors	N/A
Not yet recruiting	`NCT05100719` - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)	N/A
Recruiting	`NCT05001997` - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome	N/A
Recruiting	`NCT02953171` - Probiotics in the Treatment of Irritable Bowel Syndrome	N/A
Completed	`NCT02977975` - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome	N/A
Completed	`NCT03266068` - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed	`NCT03318614` - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster	Phase 2/Phase 3
Completed	`NCT02980406` - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level	N/A