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Trial record 2 of 97 for:    MILANO PILOT

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

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ClinicalTrials.gov Identifier: NCT04552405
Recruitment Status : Completed
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE September 17, 2020
Last Update Posted Date September 17, 2020
Actual Study Start Date  ICMJE September 12, 2017
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2020)
  • 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.
  • 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)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study
Official Title  ICMJE Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study
Brief Summary Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study
Detailed Description a prospective pilot study
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Familial Adenomatous Polyposis (FAP)
Intervention  ICMJE Dietary Supplement: Anti-inflammatory Diet
FAP individuals followed for 3 months a low-inflammatory diet
Study Arms  ICMJE FAP patients
FAP patients who underwent prophylactic total colectomy
Intervention: Dietary Supplement: Anti-inflammatory Diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2020)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 21, 2018
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04552405
Other Study ID Numbers  ICMJE INT 78/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: It will be discussed later by the staff
Responsible Party Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marco Vitellaro, MD Fondazione IRCCS Istituto Nazionale Tumori
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP