Integrative Gastroenterology - an Observational Trial

• Conditions: Crohns Disease; Ulcerative Colitis; Irritable Bowel Syndrome
• Interventions: Other: Integrative Therapy

• Registration Number: NCT02476643
• Lead Sponsor: Universität Duisburg-Essen

Brief Summary

This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.

Detailed Description

see above

Study Timeline

• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-19
• Study Start: 2015-10
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 years or older
• diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
• written informed consent

Exclusion Criteria

• participation in other clinical studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Integrative Therapy	Integrative Therapy	This group receives and integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy. Patients are admitted to the hospital ward for 14 days.

Primary Outcome Measures

Name	Time	Method
Symptoms Severity CDAI	2 weeks	Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
Symptoms Severity IBS-SSS	2 weeks	Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
Symptoms Severity CAI	2 weeks	Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)

Secondary Outcome Measures

Name	Time	Method
Disability MYMOP	24 weeks	Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)
Symptoms Severity CDAI	24 weeks	Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
Quality of Life IBS-QOL	24 weeks	Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)
Body awareness BAQ	24 weeks	Body awareness assessed by Body Awareness Questionnaire (BAQ) (Shields et al., 1989)
Body awareness BRS	24 weeks	Body awareness assessed by Body Responsiveness Scale (BRS) (Daubenmier, 2005)
Symptoms Severity IBS-SSS	24 weeks	Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
Adverse effects	2 weeks	Number of participants with any adverse effect during the study period
Symptoms Severity CAI	24 weeks	Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)
Quality of Life IBDQ	24 weeks	Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)
Self efficacy questionnaire SWE	24 weeks	Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)

Trial Locations

Locations (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte; 🇩🇪 Essen, Germany