Psychological and Dietary Treatment in IBS

Summary

Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health care.

The aim is to perform a comprehensive phenotyping of patients with IBS within the primary health care in Region Örebro County, Sweden. Following this phenotyping, the investigators will perform a prospective randomized controlled trial of two different treatments versus control as described below. Subsequently, the investigators want to evaluate the result of the treatments in order to see whether the presence of a certain phenotype can predict the efficacy of different treatments.

Our hypothesis is that the presence of certain baseline symptom characteristics in patients with IBS can predict how effective internet based cognitive behavioral therapy (iCBT) and low FODMAP (low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) treatment will be for each patient.

200 patients with IBS aged 18-65 years will be recruited from the primary health care in Region Örebro County.

The study plan is structured as follows:

1. Phenotyping of IBS patients. Investigation of the correlation between different psychological parameters, IBS symptom severity and Quality of Life.
2. The effect and outcome of 10-weeks internet-based cognitive behavioral therapy (iCBT) versus control in IBS patients.
3. The effect and outcome of 10-weeks low FODMAP diet versus control in IBS patients.
4. Comparison of iCBT and low FODMAP treatment in IBS patients and identification of baseline phenotypic characteristics predicting treatment outcome for both treatments.

Stool and blood samples will be taken before and after treatment for analysis of gut microbiota, proteomics and epigenetics and to correlate these with the clinical phenotype.

All participants will undergo phenotyping regarding GI symptoms and psychological variables using questionnaires. Participants will afterwards be randomised to either 10 weeks treatment with iCBT (80 participants), low FODMAP (80 participants) or control group (40 participants) (2:2:1 randomization). The control group will wait 10 weeks before being randomised to either iCBT (20 participants) or low FODMAP (20 participants).

Significance

This study will provide effective and individualized treatment for IBS patients. This may lead to the development of a guideline to improve the effectiveness of treatment and care for patients with IBS.

Conditions

• Irritable Bowel Syndrome

Interventions

BEHAVIORAL

Internet based cognitive behavioral therapy.

Patients will receive iCBT for 10 weeks, divided into five successive steps. The iCBT will be guided by online therapists and emphasizes acceptance of symptoms through exposure training. Patients have to report that they have worked through a treatment step to get access to the next. Patients will be encouraged to work through steps 1-4 during the first half of the treatment and to spend the latter half on step 5, in which exposure exercises will be introduced. The treatment aims to break the vicious cycle between avoidance behavior, symptom severity and functional impairment.

DIETARY_SUPPLEMENT

Low FODMAP diet therapy

Patients will receive 10 weeks of standardized treatment with low FODMAP diet consisting of 3 stages: FODMAP restriction; FODMAP reintroduction and FODMAP personalization. These stages will be covered in at least three appointments by primary care dieticians in Region Örebro County.

Sponsors & Collaborators

• Region Örebro County

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2024-03-31

Completion

2026-05-31

Countries

• Sweden

Study Locations