NCT04296552

Brain-Gut-Microbiota Interaction in IBS

Status unknown NA Last updated 30 June 2020

What this trial tests

NA trial testing Dietary lowFODMAP intervention in Irritable Bowel Syndrome in 200 participants. Status unknown.

Timeline

20 May 2019

Primary endpoint
31 December 2021

31 December 2023

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	20 May 2019
Primary completion	31 December 2021
Estimated completion	31 December 2023
Sites	1 location across Norway

Drugs / interventions tested

• Dietary lowFODMAP intervention

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
• Functional Gastrointestinal Disorders — all drugs for Functional Gastrointestinal Disorders →

Sponsor

Haukeland University Hospital

Who can join

Adults 18 to 65, any sex, with Irritable Bowel Syndrome or Functional Gastrointestinal Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut liver brain axis in diseases: the implications for therapeutic interventions.
   Yan M, Man S, Sun B, Ma L, et al · · 2023 · cited 165× · PMID 38057297 · DOI 10.1038/s41392-023-01673-4
2. Study protocol of the Bergen brain-gut-microbiota-axis study: A prospective case-report characterization and dietary intervention study to evaluate the effects of microbiota alterations on cognition and anatomical and functional brain connectivity in patients with irritable bowel
   Berentsen B, Nagaraja BH, Teige EP, Lied GA, et al · · 2020 · cited 21× · PMID 32925728 · DOI 10.1097/md.0000000000021950
3. Gluten and FODMAPs Relationship with Mental Disorders: Systematic Review.
   Aranburu E, Matias S, Simón E, Larretxi I, et al · · 2021 · cited 10× · PMID 34072914 · DOI 10.3390/nu13061894
4. Assessment of Self-Reported Executive Function in Patients with Irritable Bowel Syndrome Using a Machine-Learning Framework.
   Lundervold AJ, Hillestad EMR, Lied GA, Billing J, et al · · 2023 · cited 8× · PMID 37297966 · DOI 10.3390/jcm12113771
5. Decoding IBS: a machine learning approach to psychological distress and gut-brain interaction.
   Lundervold AJ, Billing JE, Berentsen B, Lied GA, et al · · 2024 · cited 5× · PMID 39148020 · DOI 10.1186/s12876-024-03355-z
6. A psychological symptom based machine learning model for clinical evaluation of irritable bowel syndrome.
   Haleem N, Lundervold AJ, Lied GA, Hillestad EMR, et al · · 2023 · cited 3× · PMID 37645508 · DOI 10.12688/openreseurope.15009.1
7. Brain Morphometry and Cognitive Features in the Prediction of Irritable Bowel Syndrome.
   Lundervold A, Bjørsvik BR, Billing J, Berentsen B, et al · · 2025 · cited 2× · PMID 40002622 · DOI 10.3390/diagnostics15040470
8. A 12-Week Strict Low FODMAP Diet Reduces the Severity Levels of Fatigue, Depression, Anxiety, and Inattention in Patients with Irritable Bowel Syndrome.
   Bjørkevoll SMG, Randulff Hillestad EM, Lied GA, Teige ES, et al · · 2025 · PMID 40654377 · DOI 10.1016/j.cdnut.2025.107483