Intestinal PolypsFITOPOLNCT03417258
Phytoestrogens and Colonic Adenomatous Polyps
An observational study of Intestinal Polyps, run by University of Bari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Intestinal Polyps
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2016to 24 Apr 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients (aged between 50 and 75 years) undergoing colonoscopy within 3 months from the study evaluation.
Who may be able to join
- subjects of both sexes aged between 50 and 75 years
- colonoscopy within 3 months from the study evaluation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon
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.
Read the 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.
- Conditions
- Intestinal Polyps
- Keywords
- phytoestrogens, isoflavones, adenomatous polyps, microbiome
- Medical subject headings
- Intestinal Polyps, Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with polyps | urinary phytoestrogen excretion and intestinal microbiota evaluation | |
| Patients without polyps | urinary phytoestrogen excretion and intestinal microbiota evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phytoestrogen absorption
It will be evaluated on the basis of their 24h urine excretion
Measured: one day
Secondary outcomes (1)
Intestinal microbiota
It will be evaluated on fecal samples
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start15 Jun 2016
- Primary completion15 Jun 2017
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intestinal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Barone, University of Bari
- Investigators
- Alfredo Di Leo, Study chair, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417258
- Sponsor's protocol ID
- Policlinic Hospital, Bari
- Acronym
- FITOPOL
- Status last verified
- Mar 2020
- First submitted
- 18 Jan 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7666247Atkinson 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.
PubMed 15734719Jin 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.
PubMed 22895989Kocic 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.
PubMed 23613386Setchell 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.
PubMed 12468591
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Phytoestrogens and Prevalence of Adenomatous Polyps in Human Colon
- ClinicalTrials.gov ID
- NCT03417258
- Acronym / sponsor ID
- FITOPOL / Policlinic Hospital, Bari
- Conditions
- Intestinal Polyps
- Keywords
- phytoestrogens, isoflavones, adenomatous polyps, microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with polyps | – | –urinary phytoestrogen excretion and intestinal microbiota evaluation |
| Patients without polyps | – | –urinary phytoestrogen excretion and intestinal microbiota evaluation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients (aged between 50 and 75 years) undergoing colonoscopy within 3 months from the study evaluation.
Key inclusion criteria (2 listed)
- subjects of both sexes aged between 50 and 75 years
- colonoscopy within 3 months from the study evaluation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phytoestrogen absorption
Time frame: one day
It will be evaluated on the basis of their 24h urine excretion
1 secondary outcome
Intestinal microbiota
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Background: PubMed 7666247Xu 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.
- Background: PubMed 15734719Atkinson 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.
- Background: PubMed 22895989Jin 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.
- Background: PubMed 23613386Kocic 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.
- Background: PubMed 12468591Setchell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Di Leo study chair
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Polyps, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phytoestrogen absorption (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03417258, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.