Phytoestrogens and Colonic Adenomatous Polyps

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.

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Key information

Conditions

Intestinal Polyps Adenoma Adenomatous Polyps Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinic Hospital

Bari, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

subjects of both sexes aged between 50 and 75 years
colonoscopy within 3 months from the study evaluation

Exclusion criteria

age < 50 and > 75 years
previous diagnosis of colon cancer or inflammatory bowel diseases (IBD)
Hereditary intestinal tumors (FAP, HNPCC, ...)
ongoing infections
intake, in the last 4 weeks, of drugs that alter the intestinal bacterial flora
creatinine clearance below 60 ml/min
liver failure

Treatment and study plan

Primary outcomes

Phytoestrogen absorption

Time frame: one day

It will be evaluated on the basis of their 24h urine excretion

Secondary outcomes

Intestinal microbiota

Time frame: one day

It will be evaluated on fecal samples

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon

Acronym: FITOPOL

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2019
First posted: Jan 31, 2018
Registry last updated: Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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