Crohn's DiseaseNCT01231217
Green Tea in Crohn's Disease
A study testing Green tea (Camellia sinensis) and Coffee in people with Crohn's Disease, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Green tea (Camellia sinensis) and Coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Max Karner, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg, 69120
Anja Hanemann, MS, 00496221568701, anja.hanemann@med.uni-heidelberg.de
About this study
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
- Being tested
- Green tea (Camellia sinensis), Coffee
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea (Camellia sinensis)Other
Patients are recommended to drink at least 5 cups of green tea per day
CoffeeOther
Patients are recommended to drink as much coffee as they tolerate.
| Study group | Role | What they receive |
|---|---|---|
| green (or white) tea | Other | Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee Receives: Other: Green tea (Camellia sinensis) |
| coffee | Other | Patients are recommended to drink coffee but are not allowed to consume any tea Receives: Other: Coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Disease Activity Index
Assessment of clinical activity
Measured: week 16
Secondary outcomes (2)
Harvey-Bradshaw-Index
Assessment of clinical activity
Measured: week 16
Inflammatory Bowel Disease Questionnaire
Assessment of Life Quality
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Investigators
- Max Karner, MD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231217
- Sponsor's protocol ID
- GTCD-01
- Status last verified
- May 2010
- First submitted
- 27 Oct 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea in Crohn's Disease
- ClinicalTrials.gov ID
- NCT01231217
- Acronym / sponsor ID
- GTCD-01
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Oct 2010
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| green (or white) tea | Other | Other: Green tea (Camellia sinensis)Patients are recommended to drink green (or white) tea but are not allowed to consume any coffee |
| coffee | Other | Other: CoffeePatients are recommended to drink coffee but are not allowed to consume any tea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green tea (Camellia sinensis)Patients are recommended to drink at least 5 cups of green tea per day | Other | green (or white) tea |
| CoffeePatients are recommended to drink as much coffee as they tolerate. | Other | coffee |
Primary outcome
Crohn's Disease Activity Index
Time frame: week 16
Assessment of clinical activity
2 secondary outcomes
Harvey-Bradshaw-Index
Time frame: week 16
Inflammatory Bowel Disease Questionnaire
Time frame: week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Karner, MD contact
Max Karner, MD principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea (Camellia sinensis) and Coffee in people with Crohn's Disease, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anja Hanemann, MS (00496221568701, anja.hanemann@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's Disease Activity Index (time frame: week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2010.