Green Tea in Crohn's Disease

October 29, 2010 updated by: University Hospital Heidelberg
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crohn's Disease Activity Index
Time Frame: week 16
Assessment of clinical activity
week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harvey-Bradshaw-Index
Time Frame: week 16
Assessment of clinical activity
week 16
Inflammatory Bowel Disease Questionnaire
Time Frame: week 16
Assessment of Life Quality
week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Investigators

  • Principal Investigator: Max Karner, MD, University Hospital Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Study Registration Dates

First Submitted

October 27, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (Estimate)

November 1, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2010

Last Update Submitted That Met QC Criteria

October 29, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTCD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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