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

N/ACompletedNCT04552405

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano35 enrolled

Overview

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

a prospective pilot study

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Familial Adenomatous Polyposis (FAP)

Interventions

Anti-inflammatory DietDIETARY_SUPPLEMENT

FAP individuals followed for 3 months a low-inflammatory diet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy

Outcomes

Primary Outcomes

Evaluate changes in calprotectin levels

Change from baseline in calprotectin levels at 3 months and 6 months post anti-inflammatory diet consumption.

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

Secondary Outcomes

Evaluate changes in circulatory inflammatory markers

Change from baseline in circulatory inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption.

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

Evaluate the effect on polyps growth

Evaluate the effect of the anti-inflammatory diet on polyps growth in the rectal stump (in terms of number of polyps)

Time frame: baseline and 6 months post anti-inflammatory diet consumption

Evaluate changes in the number of diarrheal discharges

Change from baseline in the number of diarrheal discharges at 3 months and 6 months post anti-inflammatory diet consumption

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

Evaluate changes in the immune cell profile

Change from baseline in the immune cell profile at 3 months and 6 months post anti-inflammatory diet consumption

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

Evaluate changes in stool inflammatory markers

Change from baseline in stool inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption

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

Data from ClinicalTrials.gov

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