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NCT Number: NCT04552405

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

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

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Key information

Conditions

Familial Adenomatous Polyposis (FAP) Adenoma Adenomatous Polyposis Coli Adenomatous Polyps Colonic Diseases Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

About this study

a prospective pilot study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-inflammatory diet

Dietary Supplement

FAP individuals followed for 3 months a low-inflammatory diet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Acronym: FAPPER

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 17, 2020
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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