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NCT06117865

Digital Treatment of Irritabel Bowel Syndrome (IBS)

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
Haukeland University Hospital·ClinicalTrials.gov·behavioralNot yet recruiting
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Study focus
Disease/Condition
IBS - Irritable Bowel Syndrome
Drug/Device/Intervention
Module 1
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Haukeland University Hospital
Timeline & enrollment
Phase
N/A
Start date
Dec 01, 2023
End date
Dec 31, 2033
Enrollment
728 participants
Primary outcome

IBS-SSS

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 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.

ICD-10 classifications
Irritable bowel syndrome with predominant constipation [IBS-C]Irritable bowel syndromeIrritable bowel syndrome with predominant diarrhoea [IBS-D]Irritable bowel syndrome with mixed bowel habits [IBS-M]Other and unspecified irritable bowel syndrome
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06117865
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06117865 through Pure Global AI's free database. This phase not specified trial is sponsored by Haukeland University Hospital and is currently Not yet recruiting. The study focuses on IBS - Irritable Bowel Syndrome. Target enrollment is 728 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.