The Rifaximin Study in CVID
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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|
- Changes in inflammatory and anti-inflammatory mediators [ Time Frame: after 2 and 8 weeks after Day 0 ] [ Designated as safety issue: No ]Changes in serum/plasma/whole blood of tumor necrosis factor alpha (TNF-alpha), c reactive protein (CRP), soluble CD14 and other cytokines/chemokines.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
No Intervention: No treatment
patient receive no active treatment
Patient takes Rifaximin 550mg twice daily for 14 days
Other Name: Xifaxan
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946906
|Contact: Silje Jørgensen, MD||23070000 ext firstname.lastname@example.org|
|Contact: Borre Fevang, MD, PhDemail@example.com|
|Oslo University Hospital||Recruiting|
|Contact: Pål Aukrust +47 23070000|
|Principal Investigator: Borre Fevang|
|Sub-Investigator: Silje Jorgensen|
|Principal Investigator:||Borre Fevang, MD, Phd||Oslo University Hospital|