Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients - Trial NCT06145022
Access comprehensive clinical trial information for NCT06145022 through Pure Global AI's free database. This phase not specified trial is sponsored by Universität Duisburg-Essen and is currently Recruiting. The study focuses on Irritable Bowel Syndrome. Target enrollment is 118 participants.
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Study Focus
Sponsor & Location
Universität Duisburg-Essen
Timeline & Enrollment
N/A
Nov 10, 2023
Jul 31, 2025
Primary Outcome
Severity of IBS symptoms by IBS-SSS,Severity of IBS symptoms by IBS-SSS,Severity of IBS symptoms by IBS-SSS,overall change in health status,overall change in health status
Summary
In the planned efficacy study, a prospective randomized controlled trial will be conducted to
 investigate the extent to which a multimodal stress reduction and lifestyle modification
 program can be reflected in patients with irritable bowel syndrome (IBS) within the framework
 of a clinical study. For this purpose, 118 patients with IBS will be enrolled in a clinical
 study. The intervention group will participate in a partial outpatient multimodal stress
 reduction and lifestyle modification program over 10 weeks, while the waitlist control group
 will only receive an educational session and written information on treatment and self-help
 options. The primary research question encompasses the examination of the program's impact on
 the severity of symptoms associated with irritable bowel syndrome (measured with the
 IBS-Symptom Severity Scale [IBS-SSS]) and additionally its influence on quality of life,
 stress, and mental well-being. Another aspect of the study is the utilization of medical
 services (e.g., comparing the number of doctor visits; intake of prescribed and
 over-the-counter medications). Additionally, a comparison of days of work disability will be
 conducted.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06145022
Non-Device Trial