Brain-Gut-Microbiota Interaction in IBS

Status Recruiting

Clinical Trial Summary

Are you what you eat? How can dietary components influence microbial composition of the gut and function of the peripheral and central nervous system? The gut and brain is linked through complex mechanisms of sensorimotor functions of the immune system, the hypothalamic-pituitary-adrenal-axis, the enteric nervous system and microbiota.

In this project, a multitude of factors contributing to the bidirectional neurobiological communication along the brain-but-axis will be investigated. No disease of the brain-gut axis has been elucidated, therefore our investigations involves approaching a large span of components and processes involved in the axis. This study is carried out as a case-report study (baseline, IBS n=100, healthy controls n=40) followed by a dietary intervention (IBS-D n=60). Through multivariate analyses, the investigators will identify patterns of factors contributing to patient symptomatology and pathology, followed by big data analysis leading to stratification of sub-classification of irritable bowel syndrome (IBS).

Clinical Trial Description

Data from deep phenotype characterization of 100 patients with IBS and 40 healthy age (between 18 and 65) and gender-matched controls will be collected between May 2019 and December 2021. Psychometric tests, questionnaires, biological samples (blood, faeces, saliva and GI biopsies from antrum, duodenum and sigmoid colon), assessment of gastric accommodation and emptying using transabdominal ultrasound, vagal activity, and functional and structural magnetic resonance imaging (MRI) of the brain, will be carried out. A subgroup of 60 patients with IBS-D will be further included in a 12-week low Fermentable Oligo-, Di-, Mono-saccharides And Polyols (FODMAP) dietary intervention-study to determine short and long-term effects of diet on symptoms, microbiota composition, molecular GI signatures, cognition and behavioural traits, and structural and functional brain signatures. Deep machine learning, prediction tools and big data analysis will be used for multivariate analysis allowing disease stratification and diagnostic biomarker detection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04296552
Study type	Interventional
Source	Haukeland University Hospital
Contact	Birgitte Berentsen, PhD
Phone	+4791545159
Email	birgitte.berentsen1@helse-bergen.no
Status	Recruiting
Phase	N/A
Start date	May 20, 2019
Completion date	December 31, 2023

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	`NCT03266068` - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed	`NCT02977975` - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome	N/A
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