Clinical trial · Interventional
Preventive Anti-inflammatory Diet to Reduce Gastro-intestinal Inflammation in FAP Patients: a Prospective Pilot Study
NCT04552405CI-TRIAL-00047200FAPPERcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Preventive anti-inflammatory diet to reduce gastro-intestinal inflammation in FAP patients: a prospective pilot study
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Adenomatous Polyposis (FAP) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-inflammatory Diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FAP patients
- description
- FAP patients who underwent prophylactic total colectomy
- interventionNames
- Dietary Supplement: Anti-inflammatory Diet
Primary outcomes (1)
- measure
- Evaluate changes in calprotectin levels
- timeFrame
- baseline, at 3 months and 6 months post anti-inflammatory diet consumption.
- description
- Change from baseline in calprotectin levels at 3 months and 6 months post anti-inflammatory diet consumption.
Secondary outcomes (5)
- measure
- Evaluate changes in circulatory inflammatory markers
- timeFrame
- baseline, at 3 months and 6 months post anti-inflammatory diet consumption.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (41)
- BACKGROUNDVasen HF, Moslein G, Alonso A, Aretz S, Bernstein I, Bertario L, Blanco I, Bulow S, Burn J, Capella G, Colas C, Engel C, Frayling I, Friedl W, Hes FJ, Hodgson S, Jarvinen H, Mecklin JP, Moller P, Myrhoi T, Nagengast FM, Parc Y, Phillips R, Clark SK, de Leon MP, Renkonen-Sinisalo L, Sampson JR, Stormorken A, Tejpar S, Thomas HJ, Wijnen J. Guidelines for the clinical management of familial adenomatous polyposis (FAP). Gut. 2008 May;57(5):704-13. doi: 10.1136/gut.2007.136127. Epub 2008 Jan 14. PMID 18194984
- BACKGROUNDUllman TA, Itzkowitz SH. Intestinal inflammation and cancer. Gastroenterology. 2011 May;140(6):1807-16. doi: 10.1053/j.gastro.2011.01.057. PMID 21530747
- BACKGROUNDGiardiello FM, Hamilton SR, Krush AJ, Piantadosi S, Hylind LM, Celano P, Booker SV, Robinson CR, Offerhaus GJ. Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis. N Engl J Med. 1993 May 6;328(18):1313-6. doi: 10.1056/NEJM199305063281805. PMID 8385741
- BACKGROUNDDolan KT, Chang EB. Diet, gut microbes, and the pathogenesis of inflammatory bowel diseases. Mol Nutr Food Res. 2017 Jan;61(1):10.1002/mnfr.201600129. doi: 10.1002/mnfr.201600129. Epub 2016 Aug 15. PMID 27346644
- BACKGROUNDNeuhouser ML, Schwarz Y, Wang C, Breymeyer K, Coronado G, Wang CY, Noar K, Song X, Lampe JW. A low-glycemic load diet reduces serum C-reactive protein and modestly increases adiponectin in overweight and obese adults. J Nutr. 2012 Feb;142(2):369-74. doi: 10.3945/jn.111.149807. Epub 2011 Dec 21. PMID 22190020
- BACKGROUNDEsmaillzadeh A, Kimiagar M, Mehrabi Y, Azadbakht L, Hu FB, Willett WC. Fruit and vegetable intakes, C-reactive protein, and the metabolic syndrome. Am J Clin Nutr. 2006 Dec;84(6):1489-97. doi: 10.1093/ajcn/84.6.1489. PMID 17158434
- BACKGROUNDAzadbakht L, Esmaillzadeh A. Red meat intake is associated with metabolic syndrome and the plasma C-reactive protein concentration in women. J Nutr. 2009 Feb;139(2):335-9. doi: 10.3945/jn.108.096297. Epub 2008 Dec 11.