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Integrative Gastroenterology - an Observational Trial (InteGast)

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ClinicalTrials.gov Identifier: NCT02476643
Recruitment Status : Active, not recruiting
First Posted : June 19, 2015
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Romy Lauche, 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.

Condition or disease Intervention/treatment
Crohns Disease Ulcerative Colitis Irritable Bowel Syndrome Other: Integrative Therapy

Detailed Description:
see above

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine
Actual Study Start Date : October 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Symptoms Severity IBS-SSS [ Time Frame: 2 weeks ]
    Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)

  2. Symptoms Severity CAI [ Time Frame: 2 weeks ]
    Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)

  3. Symptoms Severity CDAI [ Time Frame: 2 weeks ]
    Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)


Secondary Outcome Measures :
  1. Symptoms Severity IBS-SSS [ Time Frame: 24 weeks ]
    Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)

  2. Symptoms Severity CAI [ Time Frame: 24 weeks ]
    Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)

  3. Symptoms Severity CDAI [ Time Frame: 24 weeks ]
    Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)

  4. Disability MYMOP [ Time Frame: 2 weeks ]
    Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)

  5. Disability MYMOP [ Time Frame: 24 weeks ]
    Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)

  6. Quality of Life IBS-QOL [ Time Frame: 2 weeks ]
    Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)

  7. Quality of Life IBS-QOL [ Time Frame: 24 weeks ]
    Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)

  8. Quality of Life IBDQ [ Time Frame: 2 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)

  9. Quality of Life IBDQ [ Time Frame: 24 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)

  10. Self efficacy questionnaire SWE [ Time Frame: 2 weeks ]
    Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)

  11. Self efficacy questionnaire SWE [ Time Frame: 24 weeks ]
    Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)

  12. Body awareness BAQ [ Time Frame: 24 weeks ]
    Body awareness assessed by Body Awareness Questionnaire (BAQ) (Shields et al., 1989)

  13. Body awareness BRS [ Time Frame: 24 weeks ]
    Body awareness assessed by Body Responsiveness Scale (BRS) (Daubenmier, 2005)

  14. Adverse effects [ Time Frame: 2 weeks ]
    Number of participants with any adverse effect during the study period



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476643


Locations
Germany
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Gustav Dobos, Prof, MD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Responsible Party: Romy Lauche, Principal Investigator, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02476643     History of Changes
Other Study ID Numbers: 15-6183-BO InteGast
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Colonic Diseases, Functional