Green Tea in Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Green tea (Camellia sinensis)
Coffee
Sponsored by
About this trial
This is an interventional supportive care trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University Hospital HeidelbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
green (or white) tea
coffee
Arm Description
Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee
Patients are recommended to drink coffee but are not allowed to consume any tea
Outcomes
Primary Outcome Measures
Crohn's Disease Activity Index
Assessment of clinical activity
Secondary Outcome Measures
Harvey-Bradshaw-Index
Assessment of clinical activity
Inflammatory Bowel Disease Questionnaire
Assessment of Life Quality
Full Information
NCT ID
NCT01231217
First Posted
October 27, 2010
Last Updated
October 29, 2010
Sponsor
University Hospital Heidelberg
1. Study Identification
Unique Protocol Identification Number
NCT01231217
Brief Title
Green Tea in Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Heidelberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
green (or white) tea
Arm Type
Other
Arm Description
Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee
Arm Title
coffee
Arm Type
Other
Arm Description
Patients are recommended to drink coffee but are not allowed to consume any tea
Intervention Type
Other
Intervention Name(s)
Green tea (Camellia sinensis)
Intervention Description
Patients are recommended to drink at least 5 cups of green tea per day
Intervention Type
Other
Intervention Name(s)
Coffee
Intervention Description
Patients are recommended to drink as much coffee as they tolerate.
Primary Outcome Measure Information:
Title
Crohn's Disease Activity Index
Description
Assessment of clinical activity
Time Frame
week 16
Secondary Outcome Measure Information:
Title
Harvey-Bradshaw-Index
Description
Assessment of clinical activity
Time Frame
week 16
Title
Inflammatory Bowel Disease Questionnaire
Description
Assessment of Life Quality
Time Frame
week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Hanemann, MS
Phone
00496221568701
Email
anja.hanemann@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Max Karner, MD
Email
max.karner@email.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Karner, MD
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Hanemann, MS
Phone
00496221568701
Email
anja.hanemann@med.uni-heidelberg.de
12. IPD Sharing Statement
Learn more about this trial
Green Tea in Crohn's Disease
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