The effects of the local acting antibiotic Rifaximin on markers of inflammation in the blood by changing the bacterial composition in the gut, in patients with common variable immunodeficiency.
- Conditions
- Adult patients with the diagnosis of Common variable deficiency and fulfill the inclusion and exclusion criteria, will be invited to participate in the study.Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-000883-27-NO
- Lead Sponsor
- Oslo University hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
The patients will be recruited from the Section of Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet.
All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
•A diagnosis of CVID based on ESID guidelines
•18 = and <75 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
•Previous treatment with antibiotics within the last 12 weeks
•History of hypersensitivity to Rifaximin or other rifamycin derived antimicrobial agents, or any of the components of XIFAXAN
•Comorbidity not related to CVID (e.g., cardiovascular disorders].
•Polypharmica with increased risk for interactions.
•Malignancy of any cause
•Impaired kidney function (i.e., estimated glomerulus filtration rate <50 ml/minute/1.73 m2]
•Alanine aminotransferase > 150 U/l or established liver cirrhoses.
•Pregnant or planning to be pregnant in the study period to avoid interference of pregnancy with gut microbiota (not because of toxicity].
•Nursing
•On-going infection, including GI infection
•The use of probiotics for the recent 6 months
•Any immunosuppressive drugs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method