Familial Adenomatous Polyposis (FAP)
Conditions
Keywords
FAP, Familial Adenomatous Polyposis
Brief summary
Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study
Detailed description
a prospective pilot study
Interventions
DIETARY_SUPPLEMENTAnti-inflammatory Diet
FAP individuals followed for 3 months a low-inflammatory diet
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate changes in calprotectin levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate changes in circulatory inflammatory markers | 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. |
| Evaluate the effect on polyps growth | 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) |
| Evaluate changes in the number of diarrheal discharges | 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 |
| Evaluate changes in the immune cell profile | 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 |
| Evaluate changes in stool inflammatory markers | 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 |
Countries
Italy
Outcome results
None listed