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Colorectal Serrated AdenomasPhase 2MIRACLENCT01360320

Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

A Phase 2 study testing Green tea extract of Camellia Sinensis in people with Colorectal Serrated Adenomas and Colorectal Tubular Adenomas, run by Martin-Luther-Universität Halle-Wittenberg at 21 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
Green tea extract of Camellia Sinensis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,001 participants
Where
21 sitesGermany
Study dates
Nov 2011to Jul 2019
Phase
Phase 2
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 50-80 years of age
  • Histologically confirmed colorectal adenomas or serrated lesions removed during colonoscopy within the last 6 months
  • Good performance status (ECOG < 2) at study entrance
  • Written informed consent.

Who cannot join

  • History of hereditary nonpolyposis colorectal cancer (HNPCC) or familial adenomatous polyposis (FAP)
  • History of colon or rectal cancer, other concomitant cancers with the exemption of basalioma or curative treated cancers without actual anticancer medication.
  • Intestinal malabsorption, short bowel syndrome or surgical bowel interventions leading to malabsorption
  • Liver failure (hepatitis, cirrhosis, elevation of liver enzymes ALT, AST or bilirubin to more than 2.5 fold of the reference levels)
  • Inflammatory bowel disease
  • Regular intake of NSAIDs (also Cox2 inhibitors) for more than 3 months per year except of low-dose aspirin (100 mg per day)
Show all 10Show fewer
  • Immunosuppressive medication
  • Impaired capacity to consent or who are impaired in swallowing a pill
  • Regular consumption of green tea extract as nutritional supplement (with a content of EGCG of more than 100mg per day) of longer than 6 months during the past two years
  • Allergic reactions towards green tea

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Germany21 sites

  • Ostalb-Klinikum Aalen, Medizinische Klinik 1, Sekretariat Prof. Kleber

    Aalen, 73430

  • Klinikum Altenburger Land, Gastroenterologie

    Altenburg, 04600

  • Klinikum Augsburg, III. Med. Klinik

    Augsburg, 86156

  • Krankenhaus Bietigheim-Bissingen, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie

    Bietigheim-Bissingen, 74321

  • Krankenhaus Buchholz, Abteilung Innere Medizin

    Buchholz, 21244

  • Kliniken der Stadt Köln gGmbH, Krankenhaus Holweide -Medizinische Klinik-

    Cologne

  • Klinikum Esslingen, Klinik für Innere Medizin, Onkologie, Gastroenterologie

    Esslingen am Neckar, 73730

  • Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald, Klinik und Poliklinik für Innere Medizin A

    Greifswald, 17475

  • Dr. Zeisler, Praxis für Innere Medizin und Gastroenterologie

    Halle, 06108

  • Dres. Fechner/Behrens/Steudel - Gastroenterologisch-Onkologische Praxisklinik

    Halle, 06108

  • Dr. Frank-Gleich Praxis für Innere Medizin und Gastroenterologie

    Halle, 06110

  • Universitätsklinikum Halle, Klinik für Innere Medizin I

    Halle, 06120

  • Klinikum Ludwigsburg, Medizinische Klinik I

    Ludwigsburg, 71640

  • Diakoniekrankenhaus Mannheim, Medizinische Klinik II

    Mannheim, 68163

  • Klinik Mühldorf Abt.Gastroenterologie

    Mühldorf, 84453

  • Klinikum Bogenhausen, Interdisziplinäre Onkologische Tagklinik

    München, 81525

  • II. Medizinische Klinik und Poliklinik der TU München, Klinikum rechts der Isar

    Munich, 81675

  • Regio Kliniken Pinneberg

    Pinneberg, 25421

  • Klinikum St. Elisabeth, I. Medizinische Klinik

    Straubing, 94315

  • Universitätsklinikum Ulm, Klinik für Innere Medizin I

    Ulm, 89081

  • Evangelisches Krankenhaus Wesel, Abteilung Innere Medizin

    Wesel, 46485

Other trials in Germany

About this study

This is a randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.

Read the detailed description

Prevention of colorectal cancer is a major health care issue because of the high incidence of this cancer. So far, pharmaceutical chemoprevention has not gained widespread acceptance due to side effects of the chemopreventive agents used. Nutraceuticals such as polyphenols from tea plants have demonstrated remarkable therapeutic and preventive effects in molecular, epidemiological and clinical trials. However, controlled trials demonstrating the efficacy of nutraceuticals fo the prevention of colorectal cancer are largely missing.

The investigators present this randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.

Patients who underwent polypectomy for colonic polyps will be randomized after a one month verum run-in period to receive either 150mg EGCG two times daily or placebo over the course of three years. The beneficial safety profile of decaffeinated green tea extract, the quantifiable and known active content EGCG, and the accumulating evidence on its cancer preventive potential require in our view a validation of this compound for the "nutriprevention" of colorectal adenoma. Good accessibility and low costs might render this nutraceutical a top candidate for a wider use as food supplement in colon cancer prevention.

Being tested
Green tea extract of Camellia Sinensis, Green tea extract of Camellia Sinensis followed by placebo
Keywords
Green tea, polyphenol, catechin, EGCG, Epigallocatechin gallate, colorectal adenoma, adenoma prevention, colon cancer prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Green tea extract of Camellia SinensisDietary supplement

    Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG

    • Run-in period with 150mg EGCG two times daily (p.o) for 4 weeks
    • 150mg EGCG two times daily (p.o.) over the course of three years.
    • Colonoscopy after 3 years

  • Green tea extract of Camellia Sinensis followed by placeboDietary supplement

    Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG

    • Run-in period with 150mg EGCG two times daily (p.o.) for 4 weeks
    • Placebo two times daily (p.o.) over the course of three years
    • Colonoscopy after 3 years
Study groups in NCT01360320
Study groupRoleWhat they receive
Green tea extractExperimentalPowdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG, bid for 3 years
Receives: Dietary Supplement: Green tea extract of Camellia Sinensis
PlaceboPlacebo comparatorPlacebo, packed in hard gelatine capsules, bid for 3 years
Receives: Dietary Supplement: Green tea extract of Camellia Sinensis followed by placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy

    Measured: 3 years

Secondary outcomes (9)

  1. Occurrences of colorectal adenomas or mucosal lesions

    Measured: 3 years

  2. Number of colorectal adenomas or mucosal lesions

    Measured: 3 years

  3. Size of colorectal adenomas or mucosal lesions

    Measured: 3 years

  4. Localization of colorectal adenomas or mucosal lesions

    Measured: 3 years

  5. Histological subtypes of colorectal adenomas or mucosal lesions

    Measured: 3 years

  6. Invasive growth of colorectal adenomas or mucosal lesions

    Measured: 3 years

  7. Incidence of colorectal carcinoma

    Measured: 3 years

  8. Translational research

    Genetic and biochemical biomarkers for recurrence of adenoma or development of dysplasia and carcinoma (blood samples and histological in tissue samples of the colorectal lesions)

    Measured: 3 years

  9. Toxicity and feasibility

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMay 2019
  4. Study completionJul 2019

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,001 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01360320
Sponsor's protocol ID
MIRACLE
Acronym
MIRACLE
Status last verified
Sep 2019
First submitted
23 May 2011
Last updated
20 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Stingl JC, Ettrich T, Muche R, Wiedom M, Brockmoller J, Seeringer A, Seufferlein T. Protocol for minimizing the risk of metachronous adenomas of the colorectum with green tea extract (MIRACLE): a randomised controlled trial of green tea extract versus placebo for nutriprevention of metachronous colon adenomas in the elderly population. BMC Cancer. 2011 Aug 18;11:360. doi: 10.1186/1471-2407-11-360.

    PubMed 21851602

  • Melzer A, Sturm N, Rohlmann F, Muche R, Stingl J, Ettrich TJ, Seufferlein T. Interest in complementary and alternative medicine among participants in a study on cancer prevention by green tea extract - results from an expert-based survey of MIRACLE trial participants. BMC Complement Med Ther. 2025 Oct 2;25(1):350. doi: 10.1186/s12906-025-05087-3.

    PubMed 41039315

  • Stingl J, Scholl C, Steffens M, Koczera P, Muche R, Rohlmann F, Ettrich T, Seufferlein T. Genomewide association analysis on green tea chemoprevention of colorectal adenoma: the importance of SLCO1A2 variants. Pharmacogenomics. 2025 Apr-Apr;26(5-6):157-164. doi: 10.1080/14622416.2025.2510186. Epub 2025 May 28.

    PubMed 40433816

  • Seufferlein T, Ettrich TJ, Menzler S, Messmann H, Kleber G, Zipprich A, Frank-Gleich S, Algul H, Metter K, Odemar F, Heuer T, Hugle U, Behrens R, Berger AW, Scholl C, Schneider KL, Perkhofer L, Rohlmann F, Muche R, Stingl JC. Green Tea Extract to Prevent Colorectal Adenomas, Results of a Randomized, Placebo-Controlled Clinical Trial. Am J Gastroenterol. 2022 Jun 1;117(6):884-894. doi: 10.14309/ajg.0000000000001706. Epub 2022 Feb 25.

    PubMed 35213393

  • Scholl C, Lepper A, Lehr T, Hanke N, Schneider KL, Brockmoller J, Seufferlein T, Stingl JC. Population nutrikinetics of green tea extract. PLoS One. 2018 Feb 21;13(2):e0193074. doi: 10.1371/journal.pone.0193074. eCollection 2018.

    PubMed 29466429

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Green tea extract of Camellia Sinensis in people with Colorectal Serrated Adenomas and Colorectal Tubular Adenomas, run by Martin-Luther-Universität Halle-Wittenberg at 21 sites 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01360320, which also lists 5 linked publications.

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 20 Sep 2019.

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