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

Familial Adenomatous Polyposis (FAP) Clinical Trial

— FAPPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552405
• Other study ID #: INT 78/17
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: February 21, 2018

Study information

• Verified date: May 2020
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

a prospective pilot study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 21, 2018
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Familial Adenomatous Polyposis (FAP)
• Inflammation

Intervention

Dietary Supplement:
• Anti-inflammatory Diet
FAP individuals followed for 3 months a low-inflammatory diet

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate changes in circulatory inflammatory markers	Change from baseline in circulatory inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption.	baseline, at 3 months and 6 months post anti-inflammatory diet consumption.
Secondary	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)	baseline and 6 months post anti-inflammatory diet consumption
Secondary	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	baseline, at 3 months and 6 months post anti-inflammatory diet consumption
Secondary	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	baseline, at 3 months and 6 months post anti-inflammatory diet consumption
Secondary	Evaluate changes in stool inflammatory markers	Change from baseline in stool inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption	baseline, at 3 months and 6 months post anti-inflammatory diet consumption