Green Tea in Crohn's Disease

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01231217

Enrollment

Registered

2010-11-01

Start date

2010-10-31

Completion date

Unknown

Last updated

2010-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

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.

Interventions

OTHERGreen tea (Camellia sinensis)

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

OTHERCoffee

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Crohn's Disease Activity Index	week 16	Assessment of clinical activity

Secondary

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

Countries

Germany

Contacts

Primary ContactAnja Hanemann, MS

anja.hanemann@med.uni-heidelberg.de00496221568701

Backup ContactMax Karner, MD

max.karner@email.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026