Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Brief Summary:
Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study

Condition or disease Intervention/treatment Phase
Familial Adenomatous Polyposis (FAP) Dietary Supplement: Anti-inflammatory Diet Not Applicable

Detailed Description:
a prospective pilot study

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : February 21, 2018
Actual Study Completion Date : February 21, 2018


Arm Intervention/treatment
FAP patients
FAP patients who underwent prophylactic total colectomy
Dietary Supplement: Anti-inflammatory Diet
FAP individuals followed for 3 months a low-inflammatory diet




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04552405


Locations
Layout table for location information
Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milano, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Layout table for investigator information
Principal Investigator: Marco Vitellaro, MD Fondazione IRCCS Istituto Nazionale Tumori
Publications:

Layout table for additonal information
Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT04552405    
Other Study ID Numbers: INT 78/17
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It will be discussed later by the staff

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
FAP
Familial Adenomatous Polyposis
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenomatous Polyposis Coli
Inflammation
Pathologic Processes
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn
Anti-Inflammatory Agents