The Hasselt APPendicitis Immunology and Environmental Cohort STudy

Appendicitis Clinical Trial

— HAPPIEST  

Official title:

The Hasselt APPendicitis Immunology and Environmental Cohort STudy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02391675
• Other study ID #: 12.17/infect12.03
• Status: Active, not recruiting
• Start date: June 2012
• Est. completion date: October 2018

Study information

• Verified date: May 2018
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The Hasselt Appendicitis Immunology and Environmental Study (HAPPIEST) aims at characterizing factors that influence the development and severity of acute appendicitis. In a cohort of 300 patients and 300 controls, environmental factors as well as genetic make-up of the innate immune system, focusing mainly on pattern recognition, will be analyzed in order to gain insight in their relative importance in the pathology of appendicitis. Furthermore, populations of micro-organisms present in the gut of patients will be characterized, and the interaction between relevant micro-organisms and the innate immune system will be analyzed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 308
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 85 Years

Eligibility

Inclusion Criteria:

• Acute appendicitis

• Appendectomy within 7 days after onset of symptoms

• Signed informed consent

Exclusion Criteria:

• Appendectomy 7 days or more after onset of symptoms

• Participation in any clinical investigational drug study within 4 weeks of screening

• Severe, life-threatening disease with a life expectancy of less than 2 months.

Related Conditions & MeSH terms

• Appendicitis

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt	Limburg
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital, Radboud University

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (4)

Rivera-Chavez FA, Peters-Hybki DL, Barber RC, Lindberg GM, Jialal I, Munford RS, O'Keefe GE. Innate immunity genes influence the severity of acute appendicitis. Ann Surg. 2004 Aug;240(2):269-77. — View Citation

Schnitzler F, Friedrich M, Wolf C, Angelberger M, Diegelmann J, Olszak T, Beigel F, Tillack C, Stallhofer J, Göke B, Glas J, Lohse P, Brand S. The NOD2 p.Leu1007fsX1008 mutation (rs2066847) is a stronger predictor of the clinical course of Crohn's disease than the FOXO3A intron variant rs12212067. PLoS One. 2014 Nov 3;9(11):e108503. doi: 10.1371/journal.pone.0108503. eCollection 2014. — View Citation

Stappers MH, Thys Y, Oosting M, Plantinga TS, Ioana M, Reimnitz P, Mouton JW, Netea MG, Joosten LA, Gyssens IC. Polymorphisms in cytokine genes IL6, TNF, IL10, IL17A and IFNG influence susceptibility to complicated skin and skin structure infections. Eur J Clin Microbiol Infect Dis. 2014 Dec;33(12):2267-74. doi: 10.1007/s10096-014-2201-0. Epub 2014 Jul 15. — View Citation

Stappers MH, Thys Y, Oosting M, Plantinga TS, Ioana M, Reimnitz P, Mouton JW, Netea MG, Joosten LA, Gyssens IC. TLR1, TLR2, and TLR6 gene polymorphisms are associated with increased susceptibility to complicated skin and skin structure infections. J Infect Dis. 2014 Jul 15;210(2):311-8. doi: 10.1093/infdis/jiu080. Epub 2014 Feb 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Questionnaire at outpatient visit	4-6 weeks after inclusion for appendicitis
Primary	Genetic susceptibility	DNA sample collected at inclusion	Within 2 years after inclusion of the last patient
Secondary	Immunology composite outcome	ex vivo peripheral blood mononuclear cell (PBMC) stimulation experiments	within 4 years
Secondary	Environmental factors	Questionnaire filled in at inclusion	Within 6 months after inclusion of the last patient