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

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

Detailed Description
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a prospective pilot study

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

Conditions
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Familial Adenomatous Polyposis (FAP)

Intervention / Treatment
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* Dietary Supplement: Anti-inflammatory Diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FAP patients<br>FAP patients who underwent prophylactic total colectomy | Dietary Supplement: Anti-inflammatory Diet<br>* FAP individuals followed for 3 months a low-inflammatory diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FAP, Familial Adenomatous Polyposis