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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in inflammatory and anti-inflammatory mediators
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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].
- •On-going infection, including GI infection
- •The use of probiotics for the recent 6 months
- •Any immunosuppressive drugs,
研究组 & 干预措施
Rifaximin
Patient takes Rifaximin 550mg twice daily for 14 days
干预措施: Rifaximin (Drug)
结局指标
主要结局
Changes in inflammatory and anti-inflammatory mediators
时间窗: 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.
次要结局
未报告次要终点
研究者
Børre Fevang
Dr
Oslo University Hospital