The Rifaximin Study in CVID

NCT01946906 | Completed Phase 4

• 3 other identifiers: 2013/10372013-000883-2713/09446-7
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Variable Immunodeficiency (CVID)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

No treatment

NO INTERVENTION

patient receive no active treatment

Rifaximin

EXPERIMENTAL

Patient takes Rifaximin 550mg twice daily for 14 days

Drug: Rifaximin

Interventions

Rifaximin DRUG

Also known as: Xifaxan

Rifaximin

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ and \<75 years of age

You may not qualify if:

• 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,

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Common Variable Immunodeficiency

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Borre Fevang, MD, Phd

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 20, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 24, 2015

Record last verified: 2014-11

Locations

NO (1)