Status:
UNKNOWN
Green Tea in Crohn's Disease
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess whether green tea or coffee influence the course and life quality of patients with mild to moderately active Crohn's disease.
Eligibility Criteria
Inclusion
- Women and men ≥ 18 years with signed informed consent,
- 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
- Pregnancy or the wish to become pregnant, breastfeeding,
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01231217
Start Date
October 1 2010
Last Update
November 1 2010
Active Locations (1)
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1
University Hospital Heidelberg
Heidelberg, Germany, 69120