Digital Treatment of Irritable Bowel Syndrome (IBS)

NCT06117865 | Active Not Recruiting

• 1 other identifier: 2023-630038
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 1

Brief Summary

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 treatmtent 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 registered 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 defined as an improvement of 50 points or more on the IBS severity scoring system at 3 months after treatment start compared to the score before treatment.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

digital treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• IBS-QOL

  3 months after treatment start

• HADS

  3 months after treatment start

Study Arms (4)

Patient education

SHAM COMPARATOR

Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3

Behavioral therapy

ACTIVE COMPARATOR

Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3; Behavioral: Module 4

Low FODMAP-diet

ACTIVE COMPARATOR

Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3; Behavioral: Module 5

Combined treatment

ACTIVE COMPARATOR

Low FODMAP-diet and behavioral therapy

Behavioral: Module 1; Behavioral: Module 2; Behavioral: Module 3; Behavioral: Module 4; Behavioral: Module 5

Interventions

Module 1 BEHAVIORAL

Module 1: Introduction to IBS by a gastroenterologist.

Behavioral therapy; Combined treatment; Low FODMAP-diet; Patient education

Module 2 BEHAVIORAL

Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.

Behavioral therapy; Combined treatment; Low FODMAP-diet; Patient education

Module 3 BEHAVIORAL

Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.

Behavioral therapy; Combined treatment; Low FODMAP-diet; Patient education

Module 4 BEHAVIORAL

Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).

Behavioral therapy; Combined treatment

Module 5 BEHAVIORAL

Module 5: Intervention: The low FODMAP diet.

Combined treatment; Low FODMAP-diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Vestlandet, 5021, Norway

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: February 28, 2025
• Study Completion (Estimated): December 31, 2033
• Last Updated: May 16, 2025

Record last verified: 2024-05

Locations

NO (1)