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NCT Number: NCT06117865

Digital Treatment of Irritable Bowel Syndrome (IBS)

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.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, Vestlandet, 5021, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Module 1

Behavioral

Module 1: Introduction to IBS by a gastroenterologist.

Module 2

Behavioral

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

Module 3

Behavioral

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

Module 4

Behavioral

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

Module 5

Behavioral

Module 5: Intervention: The low FODMAP diet.

Primary outcomes

  1. IBS-SSS

    Time frame: 3 months after treatment start

    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

Secondary outcomes

  1. IBS-QOL

    Time frame: 3 months after treatment start

    ≥10-point increase in the IBS-Qualiy of Life (IBS-QoL) at 3 months compared to the score before treatment.

  2. HADS

    Time frame: 3 months after treatment start

    ≥3-point decrease in HADS at 3 months compared to the score before treatment.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Acronym: DIGIBS

Important dates

Study start
2023
Primary completion
2025
Study completion
2033
First posted
Nov 7, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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