Clinical trial NCT02391675: The Hasselt APPendicitis Immunology and Environmental Cohort STudy
Official title: The Hasselt APPendicitis Immunology and Environmental Cohort STudy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Appendicitis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Jessa Hospital
First posted: 2015-03-18
Enrollment: 308
Sex: ALL
Minimum age (years): 5
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are asked to participate after presenting with acute appendicitis at the emergency room of Jessa Ziekenhuis, Hasselt. If the patient fits the criteria, and informed consent is signed, the patient is included in the study.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Genetic susceptibility
timeFrame: Within 2 years after inclusion of the last patient
Secondary outcomes:
measure: Immunology composite outcome
timeFrame: within 4 years
measure: Environmental factors
timeFrame: Within 6 months after inclusion of the last patient
Other outcomes:
measure: Quality of life
timeFrame: 4-6 weeks after inclusion for appendicitis
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
affiliation: Hasselt University
name: Inge C Gyssens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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. doi: 10.1097/01.sla.0000133184.10676.26.
citation: Schnitzler F, Friedrich M, Wolf C, Angelberger M, Diegelmann J, Olszak T, Beigel F, Tillack C, Stallhofer J, Goke 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.
citation: Peeters T, Penders J, Smeekens SP, Galazzo G, Houben B, Netea MG, Savelkoul PH, Gyssens IC. The fecal and mucosal microbiome in acute appendicitis patients: an observational study. Future Microbiol. 2019 Jan;14:111-127. doi: 10.2217/fmb-2018-0203. Epub 2019 Jan 21.