Psychological and Dietary Treatment in IBS

NCT04770883 | Not Yet Recruiting

• 1 other identifier: 261771
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Cognitive Behavioral Therapy; Diet Therapy; Low FODMAP Diet; Internet Based Cognitive Behavioral Therapy; Psychological Therapy; Psychological Parameters; Phenotyping of Irritable Bowel Syndrome Patients; Gastrointestinal Symptoms; Quality of Life; Irritable Bowel Syndrome Symptom Severity

Outcome Measures

Primary Outcomes (2)

• Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS)

  Measures disease-specific symptoms in IBS patients

  10 weeks

• The IBS quality of life questionnaire (IBS-QoL)

  Assessment of disease-specific quality of Life

  10 weeks

Secondary Outcomes (10)

• Patient Health Questionnaire Anxiety module (GAD-7)

  10 weeks

• Patient Health Questionnaire Depression Module (PHQ-9)

  10 weeks

• Patient Health Questionnaire Somatic symptom severity ('somatization') module (PHQ-12)

  10 weeks

• Visceral Sensitivity Index (VSI) questionnaire

  10 weeks

• The Irritable Bowel Syndrome-Behavioural Responses Questionnaire (IBSBRQ)

  10 weeks

Study Arms (3)

Internet based cognitive behavioral therapy group

EXPERIMENTAL

80 patients will be randomized to receive iCBT. Psychological therapy is effective in IBS patients. The treatment takes 10 weeks and is divided into five successive steps. Patients have to report that they have worked through a treatment step to get access to the next. The patients will be encouraged to work through steps 1-4 during the first half of the treatment and to spend the latter half of the treatment on step 5, in which exposure exercises are introduced. A psychologist/CBT therapist will manage the online therapeutic contact with the patients.

Behavioral: Internet based cognitive behavioral therapy.

Low FODMAP group

EXPERIMENTAL

80 patients will then be randomized to receive Low FODMAP diet. FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) are poorly absorbed short-chain carbohydrates including fructose (in excess of glucose), lactose, polyols, fructans and galacto-oligosaccharides. The concept of considering all these molecules collectively as a treatment for IBS is relatively new. Understanding of FODMAPs comprises mechanisms of action such as luminal distension from their osmotic effect and rapid fermentation to hydrogen. These findings have led to increased application of the low FODMAP diet to manage IBS symptoms. Treatment will undergo 10 weeks supervised monotherapy with low FODMAP diet. This will be done with the help of professional dieticians in Örebro region, who will meet the patients and inform them how this diet works as well as follow up.

Dietary Supplement: Low FODMAP diet therapy

Control group

ACTIVE COMPARATOR

The control Group (40 patients) will wait for 10 weeks before being randomised to treatment with either iCBT or low FODMAP diet.

Behavioral: Internet based cognitive behavioral therapy.; Dietary Supplement: Low FODMAP diet therapy

Interventions

Internet based cognitive behavioral therapy. BEHAVIORAL

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.

Control group; Internet based cognitive behavioral therapy group

Low FODMAP diet therapy DIETARY_SUPPLEMENT

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.

Control group; Low FODMAP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS symptom severity score of at least 175 (moderate to severe symptoms).
• Age 18 to 65 years.

You may not qualify if:

• Abnormal results on standard screening laboratory tests; this means that patients with abnormal thyroid-stimulating hormone (TSH), increased f-calprotectin or positive celiac disease serology will not be included.
• Severe psychiatric, systemic inflammatory diseases, inflammatory bowel disease and other severe diseases such as cancer.
• Current drug or alcohol abuse.
• Inability to complete questionnaires in Swedish.
• Current pharmacological treatment for their IBS symptoms, except for "over the counter" products such as loperamide or fiber.
• Ongoing use of low FODMAP (Fermentable Mono-, di-, oligosaccharides, and polyols) diet. A current lactose free or gluten free diet will not be accepted. Earlier lactose or gluten free diet will be accepted after a wash-out period of at least 2 weeks.
• Current psychological treatment.
• Current psychological treatment.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Skebäck primary health care center

Örebro, 70215, Sweden

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Ahmed Al-Ahmadi, MD

CONTACT

0046739083380; ahmed.al-ahmadi@regionorebrolan.se

Michiel van Nieuwenhoven, Docent

CONTACT

0046738068080; michiel.van-nieuwenhoven@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is an open labelled, randomized, controlled clinical trial, with a ratio 2:2:1.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2024
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

SE (1)