An observational study in Intestinal Polyps, sponsored by University of Bari. Completed at 1 site in Italy. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by University of Bari · Observational
INTRODUCTION: The data obtained by experimental studies about the influence of phytoestrogens on colorectal cancer (CRC) have been very promising. On the other hand, clinical trials have produced conflicting results. The literature suggests that some subclasses of phytoestrogens may have protective effects against CRC and colon adenomas, but most of these results come from population studies based on the dietary intake of phytoestrogens. On these premises, it is possible to hypothesize that the variability of the data reported in the literature may be due to the fact that the real absorption of phytoestrogens (by assessing their concentration in the serum or urine) and/or the ability of the single individual of producing equol was not evaluated.
PURPOSE: In the present study, the association between the phytoestrogens intake and the prevalence of colon adenomas was evaluated not only on the basis of the simply dietary intake but also on the measurement their intestinal absorption. Moreover, a specific evaluation of equol production by the intestinal flora was performed. Finally, intestinal bacteria involved in equol production were evaluated.
MATERIALS AND METHODS: Patients with sporadic colon adenomas were enrolled in group I (case) and patients without sporadic colorectal adenomas matched for sex, age and BMI were enrolled in group II (control). All participants underwent the following evaluations: BMI, dietary history (for quantitative and qualitative analysis of dietary habits), quantitative analysis of phytoestrogens (by dietary questionnaires), medications (chronic assumption of aspirin at low doses), characteristics of the polyps (for a calculation the cancer risk), analysis of urinary excretion of phytoestrogens [by high pressure liquid chromatography (HPLC)] and intestinal flora [by mass spectrometry with Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) technology]. At the enrolment, patients will be invited to assume a standard quantitative of phytoestrogens at 8:00 a.am. and collect both a fecal sample and the urine of the following 24 hrs.
66 studies on the registry are indexed under Adenomatous Polyps; 8 are open to participants now.
This study's enrollment of 30 is below the median of 598 across 17 observational studies indexed under Adenomatous Polyps.
Browse Adenomatous Polyps studies →University of Bari is the lead sponsor of 76 studies on the registry; 12 are open to participants now.
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All patients (aged between 50 and 75 years) undergoing colonoscopy within 3 months from the study evaluation.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
urinary phytoestrogen excretion and intestinal microbiota evaluation
urinary phytoestrogen excretion and intestinal microbiota evaluation
Phytoestrogen absorption
It will be evaluated on the basis of their 24h urine excretion
Time frame: one day
Intestinal microbiota
It will be evaluated on fecal samples
Time frame: one day
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2016 to primary completion in Jun 2017, 12 months.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Bari