Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study (FAPPER)

September 10, 2020 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

a prospective pilot study

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale Tumori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- FAP patients carrying mutations in APC gene, submitted to prophylactic total colectomy/IRA (with rectum preservation) and that participate to the regular endoscopic surveillance program at IRCCS-INT.

Exclusion Criteria:

  • FAP patients taking NSAIDs and/or Omega 3
  • Patients who carried MUTYH germline mutations or had no APC mutation found.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FAP patients
FAP patients who underwent prophylactic total colectomy
Dietary supplement: Anti-inflammatory Diet
FAP individuals followed for 3 months a low-inflammatory diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate changes in calprotectin levels
Time Frame: baseline, at 3 months and 6 months post anti-inflammatory diet consumption.
Change from baseline in calprotectin levels at 3 months and 6 months post anti-inflammatory diet consumption.
baseline, at 3 months and 6 months post anti-inflammatory diet consumption.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate changes in circulatory inflammatory markers
Time Frame: baseline, at 3 months and 6 months post anti-inflammatory diet consumption.
Change from baseline in circulatory inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption.
baseline, at 3 months and 6 months post anti-inflammatory diet consumption.
Evaluate the effect on polyps growth
Time Frame: baseline and 6 months post anti-inflammatory diet consumption
Evaluate the effect of the anti-inflammatory diet on polyps growth in the rectal stump (in terms of number of polyps)
baseline and 6 months post anti-inflammatory diet consumption
Evaluate changes in the number of diarrheal discharges
Time Frame: baseline, at 3 months and 6 months post anti-inflammatory diet consumption
Change from baseline in the number of diarrheal discharges at 3 months and 6 months post anti-inflammatory diet consumption
baseline, at 3 months and 6 months post anti-inflammatory diet consumption
Evaluate changes in the immune cell profile
Time Frame: baseline, at 3 months and 6 months post anti-inflammatory diet consumption
Change from baseline in the immune cell profile at 3 months and 6 months post anti-inflammatory diet consumption
baseline, at 3 months and 6 months post anti-inflammatory diet consumption
Evaluate changes in stool inflammatory markers
Time Frame: baseline, at 3 months and 6 months post anti-inflammatory diet consumption
Change from baseline in stool inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption
baseline, at 3 months and 6 months post anti-inflammatory diet consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Investigators

  • Principal Investigator: Marco Vitellaro, MD, Fondazione IRCCS Istituto Nazionale Tumori

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Actual)

February 21, 2018

Study Completion (Actual)

February 21, 2018

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT 78/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

It will be discussed later by the staff

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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