The role of persistent gastrointestinal viral infections in the development of enteropathy in children with Common Variable Immunodeficiency and secundary immunodeficiencies

Completed

• Conditions: defective antibody production of unknown cause; primary immunodeficiency; 10017966; 10021460

• Registration Number: NL-OMON39272
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 155

Inclusion Criteria

CVID: diagnosed according to the ESID criteria:
Normal to low numbers of B lymphocytes.
Impaired specific antibody production after immunisation (less than 4-fold titer increase after polysaccharide vaccination)
Low (<-2SD) serum immunoglobulin titers.
CVID-like disease: patients who do not fulfill the ESID criteria for CVID, but suffer from a similar clinical picture: at least one of the serum immunoglobulin(subclasses) is decreased (<-2SD), or there is insufficient antibody synthesis after immunisation less than 4-fold titer increase after polysaccharide vaccination). Secondly, patients suffer from recurrent infections, for which they are or have been treated with immunoglobulin substitution therapy for at least 6 months.
Healthy children: age 4-18 years
SCT patients: children aged 0-17 who will receive a stem cell transplantation (SCT) at the Wilhelmina Children's Hospital in order to treat their underlying disease, e.g. hematological malignancy, inborn metabolic disease such as Hurler's disease.

Exclusion Criteria

For all patient groups: a proven primary immunodeficiency other than CVID, e.g. X-linked agammaglobulinemia (XLA) or hyper-IgM syndrome (HIGM), or a strong suspicion of one of these diseases.
For the healthy controls and SCT patients: immune disease, pre-existent gastrointestinal tract disease (e.g. Morbus Crohn, celiac disease, ulcerative colitis)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The prevalence of enteropathogenic virus infections in children and<br /><br>adolescents with CVID(-like disease) and SCT patients<br /><br>2. An association between viral excretion and auto-/allo-immune enteropathy </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The prevalence of symptomatic and asymptomatic enteropathogenic viral<br /><br>infections in CVID(-like disease)<br /><br>2. If any viruses are found: to assess<br /><br>a. Duration of infection<br /><br>b. Specification of the pathogen<br /><br>c. Association between pathogen and clinical findings of the patient<br /><br>3. To explore the potential differences in prevalence between the pediatric<br /><br>CVID population, 'CVID-like disease' population and healthy<br /><br>children/adolescents. </p><br>