Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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green (or white) tea
Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee
Green tea (Camellia sinensis)
Patients are recommended to drink at least 5 cups of green tea per day
coffee
Patients are recommended to drink coffee but are not allowed to consume any tea
Coffee
Patients are recommended to drink as much coffee as they tolerate.
Interventions
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Green tea (Camellia sinensis)
Patients are recommended to drink at least 5 cups of green tea per day
Coffee
Patients are recommended to drink as much coffee as they tolerate.
Eligibility Criteria
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Inclusion Criteria
* Patients with proven Crohn's disease,
* Chronic-active course ≥ 3 months,
* Current CDAI ≥ 150 and ≤ 350,
* All medications for Crohn's disease have to be on a constant dosage for at least 4 weeks prior to study entry (i.e. 5-ASA, steroids),
* Ability of the participant to understand character and individual consequences of the study.
Exclusion Criteria
* Concomitant treatment with methotrexate, azathioprine or 6-mercaptopurine for \< 3 months,
* Treatment with TNF-alpha-antagonists, cyclosporine or tacrolimus \< 4 weeks prior to study entry,
* Participation in another study within the last 4 weeks,
* Ulcerative colitis or indeterminate colitis,
* Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
* Colitis for other reasons like known diverticulitis, radiation colitis, ischemic colitis or microscopic colitis,
* Malabsorption syndromes, lactose intolerance, celiac disease, exocrine pancreas insufficiency,
* Bleeding hemorrhoids,
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
* Intolerance / aversion to tea and/or coffee,
* Current treatment with antibiotics.
18 Years
ALL
No
Sponsors
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University Hospital Heidelberg
OTHER
Principal Investigators
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Max Karner, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Heidelberg
Locations
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University Hospital Heidelberg
Heidelberg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Anja Hanemann, MS
Role: primary
Other Identifiers
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GTCD-01
Identifier Type: -
Identifier Source: org_study_id