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

NCT ID: NCT04552405

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-12
• Study Completion Date: 2018-02-21

Brief Summary

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

Detailed Description

a prospective pilot study

Conditions

Familial Adenomatous Polyposis (FAP)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FAP patients

FAP patients who underwent prophylactic total colectomy

Group Type: OTHER

Anti-inflammatory Diet

Intervention Type: DIETARY_SUPPLEMENT

FAP individuals followed for 3 months a low-inflammatory diet

Interventions

Anti-inflammatory Diet

FAP individuals followed for 3 months a low-inflammatory diet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Vitellaro, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

Locations

Fondazione IRCCS Istituto Nazionale Tumori

Milan, , Italy

Countries

Italy

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Other Identifiers

INT 78/17

Identifier Type: -

Identifier Source: org_study_id