Digital Treatment of Irritabel Bowel Syndrome (IBS) (DIGIBS)

A Randomized Controlled Digital Intervention Study to Assess the Effect of Internet Delivered Interventions, the Low FODMAP-diet, Behavioral Therapy or Both, Compared to Patient Education, on Measures of Gastrointestinal Symptom Relief and Quality of Life in Patients With Irritable Bowel Syndrome

The aim of this work is to identify whether the digital treatment program Mage-tarmskolen has an effect on patients with IBS. Our secondary objectives is to address multiple aspects of digital treamtent success of the different modules. The patients will be randomized to one of four arms and will be delivered different kinds of digital treatment. All patients will have access to ask questions to a registred dietitian. Primary end point is the proportion of patients with treatment success in the low FODMAP, behavioral therapy or both groups, versus the patient education group (sham). Treatment effect is defines as an improvement of 50 points or more on the IBS severity scoring system at 3 months agter treatment start compared to the score beofre treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3; Behavioral: Module 4; Behavioral: Module 5

• Study Type: Interventional
• Enrollment (Estimated): 728
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Diagnosed with IBS in the primary or secondary healthcare service.

• Patients aged 18-70 years with IBS defined by the Rome IV criteria: Recurrent abdominal pain, on average at least 1 day per week during the previous 3 months, that is associated with two or more of the following: i) Defecation, either increased pain or pain relief, ii) Change in stool frequency, iii) Change in stool form (appearance)
• All participants >50 years: Colonoscopy within the last 5 years prior to study entry excluding other pathology
• Bank-ID and access to tablet, PC or smart phone.
• No known presence of: symptomatic endometriosis, Diabetes type 1 and 2, Malignant disease (excluding basalioma),
• No history of: severe psychiatric disorder, alcohol or drug abuse, inflammatory bowel disease, microscopic colitis, diverticulitis or ileus, major abdominal surgery (except appendectomy, cholecystectomy, caesarean section, and hysterectomy)
• No "red flags'' indicating severe undiagnosed disease: Night sweats (Repeated episodes of extreme perspiration that may soak nightclothes or bedding), Unintentional weight loss (≥ 4.5 kilograms, or 5% of normal body weight) over less than 6 months without knowing the reason, or blood in stool
• Not pregnant
• Ability to comply with protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Patient education	Behavioral: Module 1; Module 1: Introduction to IBS by a gastroenterologist.; Behavioral: Module 2; Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.; Behavioral: Module 3; Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
Active Comparator: Behavioral therapy	Behavioral: Module 1; Module 1: Introduction to IBS by a gastroenterologist.; Behavioral: Module 2; Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.; Behavioral: Module 3; Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.; Behavioral: Module 4; Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).
Active Comparator: Low FODMAP-diet	Behavioral: Module 1; Module 1: Introduction to IBS by a gastroenterologist.; Behavioral: Module 2; Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.; Behavioral: Module 3; Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.; Behavioral: Module 5; Module 5: Intervention: The low FODMAP diet.
Active Comparator: Combined treatment; Low FODMAP-diet and behavioral therapy	Behavioral: Module 1; Module 1: Introduction to IBS by a gastroenterologist.; Behavioral: Module 2; Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.; Behavioral: Module 3; Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.; Behavioral: Module 4; Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).; Behavioral: Module 5; Module 5: Intervention: The low FODMAP diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-SSS	Treatment success is defined as an improvement of ≥50 points on the IBS severity scoring system (IBS-SSS) at 3 months after treatment start, compared to the score before treatment	3 months after treatment start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBD-QOL	≥10-point increase in the IBS-Qualiy of Life (IBS-QoL) at 3 months compared to the score before treatment.	3 months after treatment start
HADS	≥3-point decrease in HADS at 3 months compared to the score before treatment.	3 months after treatment start

Collaborators and Investigators

• Sponsor: Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: digital treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: REK630038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No