NCT02391675

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

6.3 years

First QC Date

February 26, 2015

Last Update Submit

May 19, 2018

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • Genetic susceptibility

    DNA sample collected at inclusion

    Within 2 years after inclusion of the last patient

Secondary Outcomes (2)

  • Immunology composite outcome

    within 4 years

  • Environmental factors

    Within 6 months after inclusion of the last patient

Other Outcomes (1)

  • Quality of life

    4-6 weeks after inclusion for appendicitis

Study Arms (1)

Appendicitis patients

Patients presenting with acute appendicitis

Eligibility Criteria

Age5 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Acute appendicitis
  • Appendectomy within 7 days after onset of symptoms
  • Signed informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

Location

Radboud University Medical Center

Nijmegen, Gelderland, 6500-6546, 6663, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 25022448BACKGROUND

  • 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.

    PMID: 24511099BACKGROUND

  • 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.

    PMID: 15273551BACKGROUND

  • 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.

    PMID: 25365249BACKGROUND

  • 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.

    PMID: 30663346DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma, serum, appendix tissue, stool

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Inge C Gyssens, MD PhD

    Hasselt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 18, 2015

Study Start

June 1, 2012

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

BE(1)NL(1)