Brain-Gut-Microbiota Interaction in IBS

NCT04296552 | Unknown

• 1 other identifier: 2015-01621
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Short-term dietary lowFODMAP responder will be measured using IBS-symptom severity score

  A minimum of 50 point reduction in IBS-symptom severity score (range 0-500: mild (75-175), moderate (175-300) and severe (\>300), below 75 (remission))

  At 4 weeks

• Long-term dietary lowFODMAP responder will be measured using the IBS-symptom severity score

  A minimum 50 point reduction in IBS-symptom severity score (range 0-500: mild (75-175), moderate (175-300) and severe (\>300), below 75 (remission))

  At 12 weeks

Study Arms (1)

12 week lowFODMAP dietary intervention

EXPERIMENTAL

Patients with IBS-D are enrolled in a 12 week strict lowFODMAP dietary intervention study.

Other: Dietary lowFODMAP intervention

Interventions

Dietary lowFODMAP intervention OTHER

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

12 week lowFODMAP dietary intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be between 18 and 65 years of age
• Fulfil the ROME-IV criteria for IBS
• Had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with alterations in bowel habits.
• Duration at least six months.

You may not qualify if:

• Pharmacological treatment affecting the GI-tract, including treatment for depression
• Organic disease:
• coeliac disease
• inflammatory bowel disease
• neurological diseases
• diabetes
• active helicobacter pylori infection
• polycystic ovary syndrome
• Treated with systemic antibiotics within the last 3 months
• Use painkillers regularly, other than paracetamol
• Pregnant
• Previous intestinal surgery (appendectomy is OK)
• Claustrophobic or have metallic implants that are not MR compatible
• Vegan or vegetarian
• Been travelling outside Europe within the last three weeks (or plan to travel in the nearest future)

Sponsors & Collaborators

• Haukeland University Hospital: lead
• National Research Council, Spain: collaborator
• Genetic Analysis AS: collaborator
• Lovisenberg Diakonale Hospital: collaborator
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Vestlandet, 5021, Norway

RECRUITING

Related Publications (3)

• Bjorkevoll SMG, Randulff Hillestad EM, Lied GA, Teige ES, Steinsvik EK, Berentsen B, Lundervold AJ. A 12-Week Strict Low FODMAP Diet Reduces the Severity Levels of Fatigue, Depression, Anxiety, and Inattention in Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2025 Jun 6;9(7):107483. doi: 10.1016/j.cdnut.2025.107483. eCollection 2025 Jul.

  PMID: 40654377 DERIVED

• Lundervold AJ, Billing JE, Berentsen B, Lied GA, Steinsvik EK, Hausken T, Lundervold A. Decoding IBS: a machine learning approach to psychological distress and gut-brain interaction. BMC Gastroenterol. 2024 Aug 15;24(1):267. doi: 10.1186/s12876-024-03355-z.

  PMID: 39148020 DERIVED

• Berentsen B, Nagaraja BH, Teige EP, Lied GA, Lundervold AJ, Lundervold K, Steinsvik EK, Hillestad ER, Valeur J, Bronstad I, Gilja OH, Osnes B, Hatlebakk JG, Haasz J, Labus J, Gupta A, Mayer EA, Benitez-Paez A, Sanz Y, Lundervold A, Hausken T. 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 syndrome. Medicine (Baltimore). 2020 Sep 11;99(37):e21950. doi: 10.1097/MD.0000000000021950.

  PMID: 32925728 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Birgitte Berentsen, PhD

CONTACT

+4791545159; birgitte.berentsen1@helse-bergen.no

Gülen A Lied, MD., PhD

CONTACT

+4793411359; gulen.arslan.lied@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is an open, single-centre, case-control characterisation study, followed by open label dietary intervention for a subgroup of subjects with IBS-D. Exploratory trial.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: May 20, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available post microbiota-analysis until the end of the study period.

Locations

NO (1)