COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER (NCT05692024) | Clinical Trial Compass
RecruitingPhase 1/2
COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
United States80 participantsStarted 2024-03-21
Plain-language summary
This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy and radiotherapy) at least 2 months ago.
* Age 18 years or older.
* This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults.
* The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Subjects must be able and willing to follow study procedures and instructions.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
* Participants who are receiving any other investigational agents.
* Concurrent use of other anti-cancer therapy, including c…