Digital Treatment of Irritable Bowel Syndrome (IBS)

IBS - Irritable Bowel Syndrome Clinical Trial

— DIGIBS  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117865
• Other study ID #: 2023-630038
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2033

Study information

• Verified date: May 2024
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 728
• Est. completion date: December 31, 2033
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Module 1
Module 1: Introduction to IBS by a gastroenterologist.
• Module 2
Module 2:Introduction to pain physiology and how the nervous system works by a physiotherapist including practical exercises.
• Module 3
Module 3: Evidence-based guidelines for diet and lifestyle advice (NICE Guidelines) by a clinical dietitian.
• Module 4
Module 4: Intervention: behavioral therapy (exposure therapy and cognitive behavioral therapy).
• Module 5
Module 5: Intervention: The low FODMAP diet.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Vestlandet

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IBS-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
Secondary	HADS	=3-point decrease in HADS at 3 months compared to the score before treatment.	3 months after treatment start