Green Tea in Crohn's Disease

NCT01231217 | Unknown

• 1 other identifier: GTCD-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease Activity Index

  Assessment of clinical activity

  week 16

Secondary Outcomes (2)

• Harvey-Bradshaw-Index

  week 16

• Inflammatory Bowel Disease Questionnaire

  week 16

Study Arms (2)

green (or white) tea

OTHER

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

Other: Green tea (Camellia sinensis)

coffee

OTHER

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

Other: Coffee

Interventions

Green tea (Camellia sinensis) OTHER

Patients are recommended to drink at least 5 cups of green tea per day

green (or white) tea

Coffee OTHER

Patients are recommended to drink as much coffee as they tolerate.

coffee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Tea; Coffee

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Max Karner, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Hanemann, MS

CONTACT

00496221568701; anja.hanemann@med.uni-heidelberg.de

Max Karner, MD

CONTACT

max.karner@email.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: November 1, 2010
• Study Start: October 1, 2010
• Last Updated: November 1, 2010

Record last verified: 2010-05

Locations

DE (1)