Green Tea in Crohn's Disease

Not Applicable

• Conditions: Crohn's Disease
• Interventions: Other: Green tea (Camellia sinensis); Other: Coffee

• Registration Number: NCT01231217
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-29
• Last Update Submitted: 2010-10-29
• Study First Posted: 2010-11-01
• Last Update Posted: 2010-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
green (or white) tea	Green tea (Camellia sinensis)	Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee
coffee	Coffee	Patients are recommended to drink coffee but are not allowed to consume any tea

Primary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index	week 16	Assessment of clinical activity

Secondary Outcome Measures

Name	Time	Method
Harvey-Bradshaw-Index	week 16	Assessment of clinical activity
Inflammatory Bowel Disease Questionnaire	week 16	Assessment of Life Quality

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany