Irritable Bowel SyndromeNCT04296552
Brain-Gut-Microbiota Interaction in IBS
A study testing Dietary lowFODMAP intervention in people with Irritable Bowel Syndrome and Functional Gastrointestinal Disorders, run by Haukeland University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Functional Gastrointestinal Disorders
- What is being tested?
- Dietary lowFODMAP intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 20 May 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pharmacological treatment affecting the GI-tract, including treatment for depression
- Organic disease:
- coeliac disease
- inflammatory bowel disease
- neurological diseases
- diabetes
Show all 18Show fewer
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestlandet, 5021
About this study
Official title: 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
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).
Read the detailed 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.
- Being tested
- Dietary lowFODMAP intervention
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary lowFODMAP interventionOther
Twelve week strict lowFODMAP dietary intervention, involving restricted intake of fermentable carbohydrates (FODMAPs).
| Study group | Role | What they receive |
|---|---|---|
| 12 week lowFODMAP dietary intervention | Experimental | Patients with IBS-D are enrolled in a 12 week strict lowFODMAP dietary intervention study. Receives: Other: Dietary lowFODMAP intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 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))
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start20 May 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Spain, Genetic Analysis AS, Lovisenberg Diakonale Hospital, University of Bergen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296552
- Sponsor's protocol ID
- 2015-01621
- Other IDs
- 2015
- Status last verified
- Jun 2020
- First submitted
- 4 Mar 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified stool samples, blood chemistry and symptom severity scores will be shared with collaborators.
Publications
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.
PubMed 42393543Bjorkevoll 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.
PubMed 40654377Lundervold 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.
PubMed 39148020Berentsen 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.
PubMed 32925728
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04296552
- Acronym / sponsor ID
- 2015-01621
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- National Research Council, Spain, Genetic Analysis AS, Lovisenberg Diakonale Hospital, University of Bergen
- Study start
- 20 May 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 12 week lowFODMAP dietary intervention | Experimental | Other: Dietary lowFODMAP interventionPatients with IBS-D are enrolled in a 12 week strict lowFODMAP dietary intervention study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be between 18 and 65 years of age
- Fulfil the ROME-IV criteria for IBS
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary lowFODMAP interventionTwelve week strict lowFODMAP dietary intervention, involving restricted intake of fermentable carbohydrates (FODMAPs). | Other | 12 week lowFODMAP dietary intervention |
Primary outcome
Short-term dietary lowFODMAP responder will be measured using IBS-symptom severity score
Time frame: At 4 weeks
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))
Long-term dietary lowFODMAP responder will be measured using the IBS-symptom severity score
Time frame: At 12 weeks
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))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Derived from this study: PubMed 42393543Billing 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.
- Derived from this study: PubMed 40654377Bjorkevoll 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.
- Derived from this study: PubMed 39148020Lundervold 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.
- Derived from this study: PubMed 32925728Berentsen 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.
- Individual participant dataSharing planned: Yes. De-identified stool samples, blood chemistry and symptom severity scores will be shared with collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary lowFODMAP intervention in people with Irritable Bowel Syndrome and Functional Gastrointestinal Disorders, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgitte Berentsen, PhD (+4791545159, birgitte.berentsen1@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term dietary lowFODMAP responder will be measured using IBS-symptom severity score (time frame: At 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04296552, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.