Common Variable Immunodeficiency (CVID)Phase 4NCT01946906
The Rifaximin Study in CVID
A Phase 4 study testing Rifaximin in people with Common Variable Immunodeficiency (CVID), run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Common Variable Immunodeficiency (CVID)
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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]
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- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Common Variable Immunodeficiency (CVID)
- Being tested
- Rifaximin
- Medical subject headings
- Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Xifaxan
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | patient receive no active treatment |
| Rifaximin | Experimental | Patient takes Rifaximin 550mg twice daily for 14 days Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 2 and 8 weeks after Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Variable Immunodeficiency (CVID)Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Børre Fevang, Oslo University Hospital
- Investigators
- Borre Fevang, MD, Phd, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946906
- Sponsor's protocol ID
- 2013/1037
- Other IDs
- 2013-000883-27, 13/09446-7
- Status last verified
- Nov 2014
- First submitted
- 12 Sep 2013
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01946906
- Acronym / sponsor ID
- 2013/1037
- Conditions
- Common Variable Immunodeficiency (CVID)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | –patient receive no active treatment |
| Rifaximin | Experimental | Drug: RifaximinPatient takes Rifaximin 550mg twice daily for 14 days |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifaximinAlso: Xifaxan | Drug | Rifaximin |
Primary outcome
Changes in inflammatory and anti-inflammatory mediators
Time frame: after 2 and 8 weeks after Day 0
Changes in serum/plasma/whole blood of tumor necrosis factor alpha (TNF-alpha), c reactive protein (CRP), soluble CD14 and other cytokines/chemokines.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borre Fevang, MD, Phd principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin in people with Common Variable Immunodeficiency (CVID), run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in inflammatory and anti-inflammatory mediators (time frame: after 2 and 8 weeks after Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.