Integrative Gastroenterology - an Observational Trial (InteGast)

Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine

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.

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome; Ulcerative Colitis; Crohns Disease
• Intervention / Treatment: Other: Integrative Therapy

Detailed Description

see above

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45276
    • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 patients with Inflammentory Bowel Disease admitted to the Department of Internal and Integrative Medicine.

100 patients with Irritable Bowel Syndrome admitted to the Department of Internal and Integrative Medicine.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Integrative Therapy; This group receives an 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Principal Investigator: Gustav Dobos, Prof, MD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Crohn Disease
• Other Study ID Numbers: 15-6183-BO InteGast