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

NCT04552405 | Completed

• 1 other identifier: INT 78/17
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Familial Adenomatous Polyposis (FAP)

Keywords

FAP; Familial Adenomatous Polyposis

Outcome Measures

Primary Outcomes (1)

• Evaluate changes in calprotectin levels

  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 Outcomes (5)

• Evaluate changes in circulatory inflammatory markers

  baseline, at 3 months and 6 months post anti-inflammatory diet consumption.

• Evaluate the effect on polyps growth

  baseline and 6 months post anti-inflammatory diet consumption

• Evaluate changes in the number of diarrheal discharges

  baseline, at 3 months and 6 months post anti-inflammatory diet consumption

• Evaluate changes in the immune cell profile

  baseline, at 3 months and 6 months post anti-inflammatory diet consumption

• Evaluate changes in stool inflammatory markers

  baseline, at 3 months and 6 months post anti-inflammatory diet consumption

Study Arms (1)

FAP patients

OTHER

FAP patients who underwent prophylactic total colectomy

Dietary Supplement: Anti-inflammatory Diet

Interventions

Anti-inflammatory Diet DIETARY_SUPPLEMENT

FAP individuals followed for 3 months a low-inflammatory diet

FAP patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

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MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marco Vitellaro, MD

  Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: September 17, 2020
• Study Start: September 12, 2017
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: September 17, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)