The Hasselt APPendicitis Immunology and Environmental Cohort STudy

NCT ID: NCT02391675

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Appendicitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Appendicitis patients

Patients presenting with acute appendicitis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role collaborator

Jessa Hospital

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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prof. dr. Inge Gyssens

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inge C Gyssens, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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Jessa Ziekenhuis

Hasselt, Limburg, Belgium

Site Status

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Belgium Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 25022448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24511099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15273551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25365249 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30663346 (View on PubMed)

Other Identifiers

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12.17/infect12.03

Identifier Type: -

Identifier Source: org_study_id

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