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| Name | Class |
|---|---|
| National Research Council, Spain | OTHER_GOV |
| Genetic Analysis AS | UNKNOWN |
| Lovisenberg Diakonale Hospital | OTHER |
| University of Bergen |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 week lowFODMAP dietary intervention | Experimental | Patients with IBS-D are enrolled in a 12 week strict lowFODMAP dietary intervention study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary lowFODMAP intervention | Other | Twelve week strict lowFODMAP dietary intervention, involving restricted intake of fermentable carbohydrates (FODMAPs). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Subject must be between 18 and 65 years of age
Fulfil the ROME-IV criteria for IBS
Exclusion Criteria:
Pharmacological treatment affecting the GI-tract, including treatment for depression
Organic disease:
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)
Probiotics or lowFODMAP-diet within the last three weeks
Participation in any other simultaneous clinical study
Inability to comprehend and respond to questionnaires or follow dietary guidance
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birgitte Berentsen, PhD | Contact | +4791545159 | birgitte.berentsen1@helse-bergen.no | |
| Gülen A Lied, MD., PhD | Contact | +4793411359 | gulen.arslan.lied@helse-bergen.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | Vestlandet | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42393543 | Derived | Billing J, Pfabigan DM, Steinsvik EK, Lied GA, Berentsen B, Lundervold AJ. Associations between childhood behavior and current cognitive and emotional function in adults with irritable bowel syndrome-a cross sectional retrospective study. BMC Gastroenterol. 2026 Jul 2. doi: 10.1186/s12876-026-05067-y. Online ahead of print. | |
| 40654377 |
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De-identified stool samples, blood chemistry and symptom severity scores will be shared with collaborators.
The data will become available post microbiota-analysis until the end of the study period.
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004066 | Digestive System Diseases |
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| OTHER |
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.
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| 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. |
| 39148020 | 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. |
| 32925728 | 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. |