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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science