Integrative Gastroenterology - an Observational Trial
InteGast
Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 2, 2018
April 1, 2018
2.5 years
June 12, 2015
April 30, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (14)
Symptoms Severity IBS-SSS
24 weeks
Symptoms Severity CAI
24 weeks
Symptoms Severity CDAI
24 weeks
Disability MYMOP
2 weeks
Disability MYMOP
24 weeks
- +9 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- years or older
- diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
- written informed consent
You may not qualify if:
- participation in other clinical studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, 45276, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gustav Dobos, Prof, MD
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 19, 2015
Study Start
October 1, 2015
Primary Completion
April 1, 2018
Study Completion
December 1, 2018
Last Updated
May 2, 2018
Record last verified: 2018-04