on-interventional study: evaluation of gastrointestinal complaints in patients with common variable immunodeficiency

• Conditions: D83; Common variable immunodeficiency

• Registration Number: DRKS00000339
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-12
• Study Completion: 2011-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Patients of either sex aged at least 18 years of age with a current diagnosis of CVID (according to the European Society for Immunodeficiencies [ESID] criteria), receiving regular IgG replacement therapy.

Exclusion Criteria

Patients who meet the following criteria will be excluded from the analyses: currently receiving treatment with immunosuppressive drugs or corticosteroid treatment with > 15 mg per day prednisolone or equivalent; previous bowel resection surgery; positive stool culture (after standard treatment); previous clinically relevant hypersensitivity to IgG treatment; concomitant illness that in the opinion of the investigator would affect the study analyses; or current or history of alcohol or drug abuse.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of chronic diarrhoea (the abnormal passage of 3<br>or more loose or liquid stools per day for more than 6 weeks<br>out of the last 6 months)