Integrative Gastroenterology - an Observational Trial

Ulcerative Colitis Clinical Trial

— InteGast  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02476643
• Other study ID #: 15-6183-BO InteGast
• Status: Active, not recruiting
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohns Disease
• Irritable Bowel Syndrome
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

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