Clinical trial · Interventional
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
NCT01360320CI-TRIAL-00040732MIRACLEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Serrated Adenomas | — | UNRESOLVED | — |
| Colorectal Tubular Adenomas | — | UNRESOLVED | — |
| Colorectal Tubulovillous Adenomas | — | UNRESOLVED | — |
| Colorectal Villous Adenomas | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Green tea extract of Camellia Sinensis | Dietary Supplement | — | UNRESOLVED |
| Green tea extract of Camellia Sinensis followed by placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Green tea extract
- description
- Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG, bid for 3 years
- interventionNames
- Dietary Supplement: Green tea extract of Camellia Sinensis
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo, packed in hard gelatine capsules, bid for 3 years
- interventionNames
- Dietary Supplement: Green tea extract of Camellia Sinensis followed by placebo
Primary outcomes (1)
- measure
- Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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) * 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
References
Publications (5)
- BACKGROUNDStingl 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. PMID 21851602
- DERIVEDMelzer 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. PMID 41039315
- DERIVEDStingl 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. PMID 40433816
- DERIVEDSeufferlein 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. PMID 35213393
- DERIVEDScholl 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. PMID 29466429