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

Non-interventional study: evaluation of gastrointestinal complaints in patients with common variable immunodeficiency - IgG-Baxter

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00000339

Enrollment

150

Registered

2010-02-12

Start date

2009-06-30

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

D83

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Prevalence of chronic diarrhoea (the abnormal passage of 3 or more loose or liquid stools per day for more than 6 weeks out of the last 6 months)	—

Countries

Germany

Contacts

Public ContactSigune Goldacker

Universitätsklinikum Freiburg

sigune.goldacker@uniklinik-freiburg.de+49 (0) 761 270 3750

Outcome results