Phytoestrogens and Colonic Adenomatous Polyps

Completed

• Conditions: Intestinal Polyps

• Registration Number: NCT03417258
• Lead Sponsor: University of Bari

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-06-15
• Primary Completion: 2017-06-15
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Completion: 2019-04-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phytoestrogen absorption	one day	It will be evaluated on the basis of their 24h urine excretion

Secondary Outcome Measures

Name	Time	Method
Intestinal microbiota	one day	It will be evaluated on fecal samples

Trial Locations

Locations (1)

Policlinic Hospital; 🇮🇹 Bari, Italy