Trial record 7 of 29 for:    "Common Variable Immunodeficiency" OR "common variable immune deficiency"

The Rifaximin Study in CVID

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Børre Fevang, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01946906
First received: September 12, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Common Variable Immunodeficiency (CVID)
Drug: Rifaximin
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
No Intervention: No treatment
patient receive no active treatment
Experimental: Rifaximin
Patient takes Rifaximin 550mg twice daily for 14 days
Drug: Rifaximin
Other Name: Xifaxan

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946906

Contacts
Contact: Silje Jørgensen, MD 23070000 ext 73629 silje.jorgensen@oslo-universitetssykehus.no
Contact: Borre Fevang, MD, PhD 23070000 borre.fevang@rr-research.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Pål Aukrust    +47 23070000      
Principal Investigator: Borre Fevang         
Sub-Investigator: Silje Jorgensen         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Borre Fevang, MD, Phd Oslo University Hospital
  More Information

No publications provided

Responsible Party: Børre Fevang, Dr, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01946906     History of Changes
Other Study ID Numbers: 2013/1037, 2013-000883-27, 13/09446-7
Study First Received: September 12, 2013
Last Updated: March 18, 2014
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Common Variable Immunodeficiency
Immune System Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 18, 2014