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Brain-Gut-Microbiota Interaction in IBS

NCT04296552 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-06-30

No results posted yet for this study

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).

Conditions

  • Irritable Bowel Syndrome
  • Functional Gastrointestinal Disorders

Interventions

OTHER

Dietary lowFODMAP intervention

Twelve week strict lowFODMAP dietary intervention, involving restricted intake of fermentable carbohydrates (FODMAPs).

Sponsors & Collaborators

  • National Research Council, Spain

    collaborator OTHER_GOV

  • Genetic Analysis AS

    collaborator UNKNOWN

  • Lovisenberg Diakonale Hospital

    collaborator OTHER

  • University of Bergen

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04296552 on ClinicalTrials.gov