NCT06145022

Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients

Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Irritable Bowel Syndrome Patients (MBM IBS)
Universität Duisburg-Essen·ClinicalTrials.gov·behavioralRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Irritable Bowel Syndrome
Drug/Device/Intervention
lifestyle modification
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Universität Duisburg-Essen
Location
Bamberg, Germany
Timeline & enrollment
Phase
N/A
Start date
Nov 10, 2023
End date
Jul 31, 2025
Enrollment
118 participants
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
Irritable bowel syndromeOther and unspecified irritable bowel syndromeIrritable bowel syndrome with mixed bowel habits [IBS-M]Irritable bowel syndrome with predominant constipation [IBS-C]Irritable bowel syndrome with predominant diarrhoea [IBS-D]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06145022
Type
Non-Device Trial
About this record

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.

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.