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Familial Adenomatous Polyposis (FAP)FAPPERNCT04552405

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

A study testing Anti-inflammatory Diet in people with Familial Adenomatous Polyposis (FAP), run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Familial Adenomatous Polyposis (FAP)
What is being tested?
Anti-inflammatory Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteItaly
Study dates
12 Sep 2017to 21 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • FAP patients taking NSAIDs and/or Omega 3
  • Patients who carried MUTYH germline mutations or had no APC mutation found.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133

Other trials in Italy

About this study

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

Read the detailed description

a prospective pilot study

Being tested
Anti-inflammatory Diet
Keywords
FAP, Familial Adenomatous Polyposis
Medical subject headings
Adenomatous Polyposis Coli

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-inflammatory DietDietary supplement

    FAP individuals followed for 3 months a low-inflammatory diet

Study groups in NCT04552405
Study groupRoleWhat they receive
FAP patientsOtherFAP patients who underwent prophylactic total colectomy
Receives: Dietary Supplement: Anti-inflammatory Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate changes in calprotectin levels

    Change from baseline in calprotectin levels at 3 months and 6 months post anti-inflammatory diet consumption.

    Measured: baseline, at 3 months and 6 months post anti-inflammatory diet consumption.

Secondary outcomes (5)

  1. Evaluate changes in circulatory inflammatory markers

    Change from baseline in circulatory inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption.

    Measured: baseline, at 3 months and 6 months post anti-inflammatory diet consumption.

  2. 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)

    Measured: baseline and 6 months post anti-inflammatory diet consumption

  3. 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

    Measured: baseline, at 3 months and 6 months post anti-inflammatory diet consumption

  4. 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

    Measured: baseline, at 3 months and 6 months post anti-inflammatory diet consumption

  5. Evaluate changes in stool inflammatory markers

    Change from baseline in stool inflammatory markers at 3 months and 6 months post anti-inflammatory diet consumption

    Measured: baseline, at 3 months and 6 months post anti-inflammatory diet consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2020
  2. Study start12 Sep 2017
  3. Primary completion21 Feb 2018
  4. Study completion21 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04552405
Sponsor's protocol ID
INT 78/17
Acronym
FAPPER
Status last verified
May 2020
First submitted
4 May 2020
Last updated
17 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It will be discussed later by the staff

Publications

  • Vasen 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.

    PubMed 18194984

  • Ullman TA, Itzkowitz SH. Intestinal inflammation and cancer. Gastroenterology. 2011 May;140(6):1807-16. doi: 10.1053/j.gastro.2011.01.057.

    PubMed 21530747

  • 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. doi: 10.1056/NEJM199305063281805.

    PubMed 8385741

  • Dolan 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.

    PubMed 27346644

  • Neuhouser 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.

    PubMed 22190020

  • 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. doi: 10.1093/ajcn/84.6.1489.

    PubMed 17158434

  • Azadbakht 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.

    PubMed 19074209

  • 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. doi: 10.1093/ajcn/88.4.913.

    PubMed 18842776

  • 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. doi: 10.2337/dc06-2126.

    PubMed 17392557

  • de Oliveira Otto MC, Alonso A, Lee DH, Delclos GL, Jenny NS, Jiang R, Lima JA, Symanski E, Jacobs DR Jr, Nettleton JA. Dietary micronutrient intakes are associated with markers of inflammation but not with markers of subclinical atherosclerosis. J Nutr. 2011 Aug;141(8):1508-15. doi: 10.3945/jn.111.138115. Epub 2011 Jun 8.

    PubMed 21653577

  • 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.

    PubMed 23592441

  • Rankin JW, Turpyn AD. Low carbohydrate, high fat diet increases C-reactive protein during weight loss. J Am Coll Nutr. 2007 Apr;26(2):163-9. doi: 10.1080/07315724.2007.10719598.

    PubMed 17536128

  • Fu Z, Shrubsole MJ, Smalley WE, Wu H, Chen Z, Shyr Y, Ness RM, Zheng W. Lifestyle factors and their combined impact on the risk of colorectal polyps. Am J Epidemiol. 2012 Nov 1;176(9):766-76. doi: 10.1093/aje/kws157. Epub 2012 Oct 18.

    PubMed 23079606

  • Olendzki BC, Silverstein TD, Persuitte GM, Ma Y, Baldwin KR, Cave D. An anti-inflammatory diet as treatment for inflammatory bowel disease: a case series report. Nutr J. 2014 Jan 16;13:5. doi: 10.1186/1475-2891-13-5.

    PubMed 24428901

  • Samadder NJ, Gornick M, Everett J, Greenson JK, Gruber SB. Inflammatory bowel disease and familial adenomatous polyposis. J Crohns Colitis. 2013 Apr;7(3):e103-7. doi: 10.1016/j.crohns.2012.06.021. Epub 2012 Jul 17.

    PubMed 22809634

Questions about this trial

What is this clinical trial studying?

A study testing Anti-inflammatory Diet in people with Familial Adenomatous Polyposis (FAP), run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate changes in calprotectin levels (time frame: baseline, at 3 months and 6 months post anti-inflammatory diet consumption.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04552405, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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