Brain-Gut-Microbiota Interaction in IBS

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296552
• Other study ID #: 2015-01621
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2020
• Source: Haukeland University Hospital
• Contact: Birgitte Berentsen, PhD
• Phone: +4791545159
• Email: birgitte.berentsen1[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Vestlandet

Sponsors (5)

Lead Sponsor	Collaborator
Haukeland University Hospital	Genetic Analysis AS, Lovisenberg Diakonale Hospital, National Research Council, Spain, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Website for project description, participant information and contact details.