Green Tea in Crohn's Disease

University Hospital Heidelberg

Status: Unknown

Conditions: Crohn's Disease

Treatments: Other: Green tea (Camellia sinensis); Other: Coffee

Study type: Interventional

Funder types: Other

Identifiers

NCT01231217

GTCD-01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

green (or white) tea

Other group

Description:

Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee

Treatment:

Other: Green tea (Camellia sinensis)

coffee

Other group

Description:

Patients are recommended to drink coffee but are not allowed to consume any tea

Treatment:

Other: Coffee