Green Tea in Crohn's Disease

Crohn's Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01231217
• Other study ID #: GTCD-01
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2010
• Last updated: October 29, 2010
• Start date: October 2010

Study information

• Verified date: May 2010
• Source: University Hospital Heidelberg
• Contact: Anja Hanemann, MS
• Phone: 00496221568701
• Email: anja.hanemann[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crohn's Disease Activity Index	Assessment of clinical activity	week 16	No
Secondary	Harvey-Bradshaw-Index	Assessment of clinical activity	week 16	No
Secondary	Inflammatory Bowel Disease Questionnaire	Assessment of Life Quality	week 16	No