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Green Tea in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01231217
Recruitment Status : Unknown
Verified May 2010 by University Hospital Heidelberg.
Recruitment status was:  Recruiting
First Posted : November 1, 2010
Last Update Posted : November 1, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Crohn's Disease Other: Green tea (Camellia sinensis) Other: Coffee

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
green (or white) tea
Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee
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 coffee but are not allowed to consume any tea
Other: Coffee
Patients are recommended to drink as much coffee as they tolerate.



Primary Outcome Measures :
  1. Crohn's Disease Activity Index [ Time Frame: week 16 ]
    Assessment of clinical activity


Secondary Outcome Measures :
  1. Harvey-Bradshaw-Index [ Time Frame: week 16 ]
    Assessment of clinical activity

  2. Inflammatory Bowel Disease Questionnaire [ Time Frame: week 16 ]
    Assessment of Life Quality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231217


Contacts
Contact: Anja Hanemann, MS 00496221568701 anja.hanemann@med.uni-heidelberg.de
Contact: Max Karner, MD max.karner@email.de

Locations
Germany
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Anja Hanemann, MS    00496221568701    anja.hanemann@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Max Karner, MD University Hospital Heidelberg

ClinicalTrials.gov Identifier: NCT01231217     History of Changes
Other Study ID Numbers: GTCD-01
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases