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Digital Treatment of Irritabel Bowel Syndrome (IBS) - Trial NCT06117865

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.

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NCT06117865
Not yet recruiting
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06117865
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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

Study Focus

Module 1

Interventional

behavioral

Sponsor & Location

Haukeland University Hospital

Timeline & Enrollment

N/A

Dec 01, 2023

Dec 31, 2033

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 syndrome
Irritable bowel syndrome with predominant diarrhoea [IBS-D]
Irritable bowel syndrome with mixed bowel habits [IBS-M]
Other and unspecified irritable bowel syndrome

Data Source

ClinicalTrials.gov

NCT06117865

Non-Device Trial