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Phytoestrogens and Colonic Adenomatous Polyps (FITOPOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417258
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Michele Barone, 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.


Condition or disease
Intestinal Polyps

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon
Actual Study Start Date : June 15, 2016
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : April 24, 2019

Group/Cohort
Patients with polyps
urinary phytoestrogen excretion and intestinal microbiota evaluation
Patients without polyps
urinary phytoestrogen excretion and intestinal microbiota evaluation



Primary Outcome Measures :
  1. Phytoestrogen absorption [ Time Frame: one day ]
    It will be evaluated on the basis of their 24h urine excretion


Secondary Outcome Measures :
  1. Intestinal microbiota [ Time Frame: one day ]
    It will be evaluated on fecal samples


Biospecimen Retention:   Samples Without DNA
Urine, feces


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients (aged between 50 and 75 years) undergoing colonoscopy within 3 months from the study evaluation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417258


Locations
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Italy
Policlinic Hospital
Bari, Italy, 70124
Sponsors and Collaborators
University of Bari
Investigators
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Study Chair: Alfredo Di Leo University of Bari
  Study Documents (Full-Text)

Documents provided by Michele Barone, University of Bari:
Additional Information:

Publications:
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Responsible Party: Michele Barone, Researcher, University of Bari
ClinicalTrials.gov Identifier: NCT03417258    
Other Study ID Numbers: Policlinic Hospital, Bari
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michele Barone, University of Bari:
phytoestrogens
isoflavones
adenomatous polyps
microbiome
Additional relevant MeSH terms:
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Adenomatous Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms