The Rifaximin Study in CVID

Brief Title

The Rifaximin Study in CVID

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

Brief Summary

      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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Changes in inflammatory and anti-inflammatory mediators


Condition

Common Variable Immunodeficiency (CVID)

Intervention

Rifaximin

Study Arms / Comparison Groups

 No treatment
Description:  patient receive no active treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

October 2013

Completion Date

December 2014

Primary Completion Date

December 2014

Eligibility Criteria

        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,
      

Gender

All

Ages

18 Years - 74 Years

Accepts Healthy Volunteers

No

Contacts

Borre Fevang, MD, Phd, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT01946906

Organization ID

2013/1037

Secondary IDs

2013-000883-27

Responsible Party

Principal Investigator

Study Sponsor

Oslo University Hospital


Study Sponsor

Borre Fevang, MD, Phd, Principal Investigator, Oslo University Hospital


Verification Date

November 2014