Green Tea in Crohn's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University Hospital Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01231217
First received: October 27, 2010
Last updated: October 29, 2010
Last verified: May 2010
  Purpose

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 Intervention
Crohn's Disease
Other: Green tea (Camellia sinensis)
Other: Coffee

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

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Crohn's Disease Activity Index [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Assessment of clinical activity


Secondary Outcome Measures:
  • Harvey-Bradshaw-Index [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Assessment of clinical activity

  • Inflammatory Bowel Disease Questionnaire [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    Assessment of Life Quality


Estimated Enrollment: 80
Study Start Date: October 2010
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01231217     History of Changes
Other Study ID Numbers: GTCD-01
Study First Received: October 27, 2010
Last Updated: October 29, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 19, 2014