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The Hasselt APPendicitis Immunology and Environmental Cohort STudy

The Hasselt APPendicitis Immunology and Environmental Cohort STudy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02391675
Acronym
HAPPIEST
Enrollment
308
Registered
2015-03-18
Start date
2012-06-30
Completion date
2018-10-31
Last updated
2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

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.

Interventions

None listed

Sponsors

Radboud University Medical Center
CollaboratorOTHER
Jessa Hospital
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Genetic susceptibilityWithin 2 years after inclusion of the last patientDNA sample collected at inclusion

Secondary

MeasureTime frameDescription
Immunology composite outcomewithin 4 yearsex vivo peripheral blood mononuclear cell (PBMC) stimulation experiments
Environmental factorsWithin 6 months after inclusion of the last patientQuestionnaire filled in at inclusion

Other

MeasureTime frameDescription
Quality of life4-6 weeks after inclusion for appendicitisQuestionnaire at outpatient visit

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026