NCT06197308招募中早期 1 期
Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To evaluate safety of MTT in patients with PSC
研究概览
简要总结
This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). This trial will inform development of future trials in treatment of PSC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-76
- •Serum total bilirubin at screening ≤ 2x the upper limit of normal
- •Absence of biliary obstruction and malignancy by ultrasound or equivalent imaging within 6 months of study entry
- •Anticipated maintenance of current medication regimen through the treatment period (UDCA, azathioprine, corticosteroid, methotrexate, 5-ASA, biologic therapy and/or probiotic)
- •3-month washout period of obeticholic acid or other experimental therapies for PSC
- •Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.
- •Informed consent
排除标准
- •Antibiotic therapy (except vancomycin) within 3 months or anticipated antibiotic use in the course of the MTT treatment
- •Presence of complications of advanced PSC, such as hepatic encephalopathy, ascites, history of esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, and hepato-pulmonary syndrome
- •Evidence for viral hepatitis (history of Hepatitis C is eligible with undetectable HCV RNA); HIV/AIDS
- •Metabolic or inherited liver disease (e.g., Wilson's, hemochromatosis, alpha-1-antitrypsin deficiency)
- •Another disease involving bile ducts (e.g., primary biliary cholangitis, IgG4-related cholangitis, secondary sclerosing cholangitis)
- •Evidence of cirrhosis on the last magnetic resonance cholangiopancreatography (within 6 months)
- •Pregnancy or attempting to become pregnant or breastfeeding.
- •History of liver transplantation, anticipated need for liver transplantation within 12- months from randomization, or a Model of End Stage Liver Disease (MELD) score of ≥15
- •Active malignancy
- •Active alcohol overuse (>4 drinks per day for men, and >2 drinks per day for women)
- •Moderate-to-severe renal impairment with a calculated creatinine clearance of < 45 mL/min
- •Neutropenia (an absolute neutrophil count < 0.5 x 109 cells/L)
- •History of allergic reaction to vancomycin
- •History of allergic reaction to amoxicillin or other beta-lactam antibiotics
- •Any other conditions or abnormalities that, in the opinion of the investigator, may compromise the safety of the subject or interfere with the subject participating in or completing the study
- •Total colectomy
研究组 & 干预措施
PCS patients
Experimental
干预措施: oral vancomycin and oral amoxicillin (Drug)
结局指标
主要结局
To evaluate safety of MTT in patients with PSC
时间窗: 221 days
Determine the frequency of serious adverse events and other adverse events
To evaluate feasibility of MTT in patients with PSC
时间窗: 221 days
Determine proportion of subjects taking 100% of the MTT per protocol.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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