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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04552405
Other study ID # INT 78/17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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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Azadbakht L, Kimiagar M, Mehrabi Y, Esmaillzadeh A, Hu FB, Willett WC. Soy consumption, markers of inflammation, and endothelial function: a cross-over study in postmenopausal women with the metabolic syndrome. Diabetes Care. 2007 Apr;30(4):967-73. — View Citation

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Esmaillzadeh A, Azadbakht L. Home use of vegetable oils, markers of systemic inflammation, and endothelial dysfunction among women. Am J Clin Nutr. 2008 Oct;88(4):913-21. — View Citation

Esmaillzadeh 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. — View Citation

Flock MR, Rogers CJ, Prabhu KS, Kris-Etherton PM. Immunometabolic role of long-chain omega-3 fatty acids in obesity-induced inflammation. Diabetes Metab Res Rev. 2013 Sep;29(6):431-45. doi: 10.1002/dmrr.2414. Review. — View Citation

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Giardiello 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. — View Citation

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Kaaks R, Bellati C, Venturelli E, Rinaldi S, Secreto G, Biessy C, Pala V, Sieri S, Berrino F. Effects of dietary intervention on IGF-I and IGF-binding proteins, and related alterations in sex steroid metabolism: the Diet and Androgens (DIANA) Randomised Trial. Eur J Clin Nutr. 2003 Sep;57(9):1079-88. — View Citation

Laake KO, Line PD, Grzyb K, Aamodt G, Aabakken L, Røset A, Hvinden AB, Bakka A, Eide J, Bjørneklett A, Vatn MH. Assessment of mucosal inflammation and blood flow in response to four weeks' intervention with probiotics in patients operated with a J-configurated ileal-pouch-anal-anastomosis (IPAA). Scand J Gastroenterol. 2004 Dec;39(12):1228-35. — View Citation

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Mlecnik B, Bindea G, Angell HK, Maby P, Angelova M, Tougeron D, Church SE, Lafontaine L, Fischer M, Fredriksen T, Sasso M, Bilocq AM, Kirilovsky A, Obenauf AC, Hamieh M, Berger A, Bruneval P, Tuech JJ, Sabourin JC, Le Pessot F, Mauillon J, Rafii A, Laurent-Puig P, Speicher MR, Trajanoski Z, Michel P, Sesboüe R, Frebourg T, Pagès F, Valge-Archer V, Latouche JB, Galon J. Integrative Analyses of Colorectal Cancer Show Immunoscore Is a Stronger Predictor of Patient Survival Than Microsatellite Instability. Immunity. 2016 Mar 15;44(3):698-711. doi: 10.1016/j.immuni.2016.02.025. — View Citation

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Vasen HF, Möslein G, Alonso A, Aretz S, Bernstein I, Bertario L, Blanco I, Bülow S, Burn J, Capella G, Colas C, Engel C, Frayling I, Friedl W, Hes FJ, Hodgson S, Järvinen H, Mecklin JP, Møller P, Myrhøi 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. — View Citation

* Note: There are 39 references in allClick 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
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