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Brain-Gut-Microbiota Interaction in IBS

Primary Purpose

Irritable Bowel Syndrome, Functional Gastrointestinal Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Dietary lowFODMAP intervention
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject must be between 18 and 65 years of age

  • Fulfil the ROME-IV criteria for IBS

    1. 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.
    2. Duration at least six months.

Exclusion Criteria:

  • Pharmacological treatment affecting the GI-tract, including treatment for depression

  • Organic disease:

    1. coeliac disease
    2. inflammatory bowel disease
    3. neurological diseases
    4. diabetes
    5. active helicobacter pylori infection
    6. 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

Sites / Locations

  • Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

12 week lowFODMAP dietary intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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))
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))

Secondary Outcome Measures

Full Information

First Posted
March 4, 2020
Last Updated
June 28, 2020
Sponsor
Haukeland University Hospital
Collaborators
National Research Council, Spain, Genetic Analysis AS, Lovisenberg Diakonale Hospital, University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT04296552
Brief Title
Brain-Gut-Microbiota Interaction in IBS
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
National Research Council, Spain, Genetic Analysis AS, Lovisenberg Diakonale Hospital, University of Bergen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Functional Gastrointestinal Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
12 week lowFODMAP dietary intervention
Arm Type
Experimental
Arm Description
Patients with IBS-D are enrolled in a 12 week strict lowFODMAP dietary intervention study.
Intervention Type
Other
Intervention Name(s)
Dietary lowFODMAP intervention
Intervention Description
Twelve week strict lowFODMAP dietary intervention, involving restricted intake of fermentable carbohydrates (FODMAPs).
Primary Outcome Measure Information:
Title
Short-term dietary lowFODMAP responder will be measured using IBS-symptom severity score
Description
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))
Time Frame
At 4 weeks
Title
Long-term dietary lowFODMAP responder will be measured using the IBS-symptom severity score
Description
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))
Time Frame
At 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgitte Berentsen, PhD
Phone
+4791545159
Email
birgitte.berentsen1@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Gülen A Lied, MD., PhD
Phone
+4793411359
Email
gulen.arslan.lied@helse-bergen.no
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
State/Province
Vestlandet
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified stool samples, blood chemistry and symptom severity scores will be shared with collaborators.
IPD Sharing Time Frame
The data will become available post microbiota-analysis until the end of the study period.
Citations:
PubMed Identifier
32925728
Citation
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.
Results Reference
derived
Links:
URL
http://www.braingut.no
Description
Website for project description, participant information and contact details.

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Brain-Gut-Microbiota Interaction in IBS

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