Adult patients with the diagnosis of Common variable deficiency and fulfill the inclusion and exclusion criteria, will be invited to participate in the study.
Conditions
Sponsors
Oslo University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if intervention with antibiotics (i.e. Rifaximin) modifies markers of systemic inflammation by alteration of the gut microbiota.;Secondary Objective: Not Applicable;Primary end point(s): Primary Endpoint The primary endpoint will be time-dependent changes in inflammatory and anti-inflammatory mediators in plasma, serum, PBMC and whole blood. The three most important markers will be: •Serum levels of soluble CD14 [sCD14] as marker of gut leakage/systemic endotoxin exposure. •C-reactive protein [CRP] as a reliable marker of up-stream inflammation. •Serum levels of tumor necrosis factor [TNF]a which are known to be elevated in CVID patients (Aukrust, Lien et al. 1996) In addition we will examine (i) markers of endothelial cell activation [e.g., pentraxin-3, von willebrand factor], (ii) markers of macrophage activation [e.g., neopterin, sCD163] (iii) inflammatory cytokines [e.g., interleukin (IL)-1ß, IL-6, IL-8 and IL-8], (iv) anti-inflammatory cytokines [e.g. IL-10, transforming growth factor ß], (v) chemokines [e.g., CCL5, CCL19, CCL21, CXCL8, CXCL16], (vi) additional markers of gut leakage[sTLR2, high-mobility group box 1 protein, endotoxins] and (vii) T cell subpopulations [e.g., Tregs, naïve T cells, memory T cells], ;Timepoint(s) of evaluation of this end point: After Treatment: day 14 and 6 weeks after ended treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints • Compositional and time-dependent changes of the gut microflora, FA composition and bacterial metabolites. • Serum SCFA and overall FA composition ;Timepoint(s) of evaluation of this end point: After Treatment day 14 and 6 weeks after ended treatment. | — |
Countries
Norway
Contacts
Public ContactBørre Fevang
Oslo University hospital
Outcome results
None listed