Phytoestrogens and Colonic Adenomatous Polyps

NCT03417258 | Completed

• 1 other identifier: Policlinic Hospital, Bari
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Polyps

Keywords

phytoestrogens; isoflavones; adenomatous polyps; microbiome

Outcome Measures

Primary Outcomes (1)

• Phytoestrogen absorption

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

  one day

Secondary Outcomes (1)

• Intestinal microbiota

  one day

Study Arms (2)

Patients with polyps

urinary phytoestrogen excretion and intestinal microbiota evaluation

Patients without polyps

urinary phytoestrogen excretion and intestinal microbiota evaluation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients (aged between 50 and 75 years) undergoing colonoscopy within 3 months from the study evaluation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Policlinic Hospital

Bari, 70124, Italy

Location

Related Publications (5)

• Xu X, Harris KS, Wang HJ, Murphy PA, Hendrich S. Bioavailability of soybean isoflavones depends upon gut microflora in women. J Nutr. 1995 Sep;125(9):2307-15. doi: 10.1093/jn/125.9.2307.

  PMID: 7666247 BACKGROUND

• Atkinson C, Frankenfeld CL, Lampe JW. Gut bacterial metabolism of the soy isoflavone daidzein: exploring the relevance to human health. Exp Biol Med (Maywood). 2005 Mar;230(3):155-70. doi: 10.1177/153537020523000302.

  PMID: 15734719 BACKGROUND

• Jin H, Leng Q, Li C. Dietary flavonoid for preventing colorectal neoplasms. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD009350. doi: 10.1002/14651858.CD009350.pub2.

  PMID: 22895989 BACKGROUND

• Kocic B, Kitic D, Brankovic S. Dietary flavonoid intake and colorectal cancer risk: evidence from human population studies. J BUON. 2013 Jan-Mar;18(1):34-43.

  PMID: 23613386 BACKGROUND

• Setchell KD, Brown NM, Lydeking-Olsen E. The clinical importance of the metabolite equol-a clue to the effectiveness of soy and its isoflavones. J Nutr. 2002 Dec;132(12):3577-84. doi: 10.1093/jn/132.12.3577.

  PMID: 12468591 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, feces

MeSH Terms

Conditions

Intestinal Polyps; Adenomatous Polyps

Condition Hierarchy (Ancestors)

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

Study Officials

• Alfredo Di Leo

  University of Bari

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 31, 2018
• Study Start: June 15, 2016
• Primary Completion: June 15, 2017
• Study Completion: April 24, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)