Common Variable Immunodeficiency (CVID) Clinical Trial
Official title:
Effects of Rifaximin, by Modulation of the Gut Microbiota, on Markers of Systemic Inflammation in Patients With Common Variable Immunodeficiency - An Exploratory Open-label Randomized Controlled Trial
Patients with Common variable immunodeficiency (CVID) have various forms of autoimmune and
auto inflammatory disorders. The study will investigate if intervention with Rifaximin
modifies the gut microbiota with a subsequent alteration in markers of systemic immune
activation and inflammation in patients with CVID. The investigators hypothesize that the
gut microbiota of CVID patients, at least partly through interaction with the innate immune
system within the intestine, contribute to a low-grade systemic inflammation in these
patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates
systemic inflammation through modulation of the gut microbiota. The study may lead to
increased understanding of the interaction between microbiota and the immune system. The
study could give new insight into important disease processes in relation to the interaction
between the microbiota, the intestine and the systemic compartment, and potentially be the
basis of new therapeutic strategies in these patients to prevent and down-regulate the
auto-inflammatory and autoimmune complications seen in CVID. The findings could also be of
relevance for other disorders where the interaction between microbiota and intestinal and
systemic inflammation is involved such as various cardiovascular and metabolic disorders.
The investigators hypothesize that the gut microbiota of CVID patients, at least partly
through interaction with the innate immune system within the intestine, contribute to a
low-grade systemic inflammation in these patients, and that an intervention with the
non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of
the gut microbiota.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 74 Years |
| Eligibility |
Inclusion Criteria: - 18 = and <75 years of age - A diagnosis of CVID: decreased serum levels (> 2 SD) of immunoglobulin (Ig)G, IgA and/or IgM and exclusion of other forms of hypogammaglobulinemia 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- i.e. conditions or symptoms that may influence with the patient safety or compromise the study results (e.g., cardiovascular disorders, alcoholism, psychiatric disease, HIV infection etc.)]. - Polypharmacy with increased risk for interactions. i.e. patient with an extensive medication lists (e.g. 10 drugs or more) this may influence with the patient safety or compromise the study results - Malignancy of any cause - Impaired kidney function (i.e., estimated glomerulus filtration rate <50 ml/minute/1.73 m2] - Impaired liver function (Alanine aminotransferase > 150 U/l) or established liver cirrhosis. - 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, |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Norway | Oslo University Hospital | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in inflammatory and anti-inflammatory mediators | Changes in serum/plasma/whole blood of tumor necrosis factor alpha (TNF-alpha), c reactive protein (CRP), soluble CD14 and other cytokines/chemokines. | after 2 and 8 weeks after Day 0 | No |