NCT06145022

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

November 10, 2023

Last Update Submit

November 17, 2023

Conditions

Irritable Bowel Syndrome

Keywords

lifestyle modificationMind-Body medicineintegrative medicine

Outcome Measures

Primary Outcomes (5)

  • Severity of IBS symptoms by IBS-SSS

    Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS

    week 0

  • Severity of IBS symptoms by IBS-SSS

    Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS

    week 12

  • Severity of IBS symptoms by IBS-SSS

    Irritable bowel syndrome severity scoring system (IBS-SSS); 5-item questionnaire; scale from 0% (= not at all) to 100% (= very severe); cut-off of IBS-SSS scores to evaluate the severity of IBS: \< 175 for mild IBS, 175-300 for moderate IBS, and \> 300 for severe IBS

    week 36

  • overall change in health status

    Rating scale from 1 (= much worse) to 5 (= much better)

    week 12

  • overall change in health status

    Rating scale from 1 (= much worse) to 5 (= much better)

    week 36

Secondary Outcomes (27)

  • Disease related Quality of Life by IBS-QOL

    week 0

  • Disease related Quality of Life by IBS-QOL

    week 12

  • Disease related Quality of Life by IBS-QOL

    week 36

  • General Quality of Life by EQ-5D-SL

    week 0

  • General Quality of Life by EQ-5D-SL

    week 12

  • +22 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

Once a week for 10 weeks with a circumference of 60 hours with mindfulness-based stress reduction and further process of the Mind / body medicine.

Behavioral: lifestyle modification

waitlist control group

ACTIVE COMPARATOR

A unique education unit within the scope of 1,5 hours on the influence of lifestyle factors on the disease and self-help materials for the independent training. After the follow-up measurement opportunity to participate in the program.

Behavioral: waitlist control group

Interventions

lifestyle modificationBEHAVIORAL

The group intervention is carried out once a week for 10 weeks for a total of 60 hours with elements of mindfulness-based stress reduction (MBSR) and mind / body medicine. In this project, this program will be adapted to the specific needs of irritable bowel syndrome patients.

intervention group
waitlist control groupBEHAVIORAL

Participants in this group receive a one-time education unit within the scope of 1,5 hours on the influence of lifestyle factors on the disease, also self-help materials for independent training offered. Following the follow-up measure also this group is given the opportunity to participate in the multimodal stress reduction- and lifestyle modification program.

waitlist control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score \> 75

You may not qualify if:

  • Severe mental illness (e.g., clinically significant depression, substance use disorder, schizophrenia)
  • Severe comorbid somatic illness (e.g., oncological disease)
  • Pregnancy
  • Participation in other stress reduction programs or clinical studies on psychological interventions
  • Known intolerances (fructose, lactose), celiac disease, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sozialstiftung Bamberg

Bamberg, Bavaria, 96049, Germany

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Jost Langhorst, Prof. Dr.

    University of Duisburg-Essen/Sozialstiftung Bamberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Utz, PhD

CONTACT

+49 951 503sandra.utz@sozialstiftung-bamberg.de

Christine Uecker

CONTACT

+49 951 503christine.uecker@sozialstiftung-bamberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 22, 2023

Study Start

November 10, 2023

Primary Completion

December 31, 2024

Study Completion

July 31, 2025

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

DE(1)