NCT07335523招募中不适用
A Study to Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Dietary fat absorption
研究概览
简要总结
The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant. During the study, participants will:
- Consume a high fat diet
- Keep a diary of their abdominal signs and symptoms, and stool frequency and consistency
- Collect stool for laboratory testing
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants ages 7-50 years inclusive.
- •Confirmed diagnosis of ALGS
- •Status post OLT due to ALGS complications.
- •Participants currently managed with pancreatic enzyme products (PEPs) are allowed pending discontinuation of PEPs for 5 days prior to beginning the 72-hour stool collections. Participants must discontinue PEPs for the entire study period until completion.
- •Agree to adhere to a high fat diet at least 2 days prior to and during the 72-hour stool collections and monitor dietary consumption through the use of a diet diary.
- •Have a consistent caregiver for the duration of the study if applicable for enrollment of a child.
- •Capable of giving written informed consent and assent (if age appropriate).
排除标准
- •Surgical disruption of the enterohepatic circulation (e.g., biliary diversion).
- •Subjects with alternative etiologies of EPI (e.g., chronic panreatitis, pancreatic resection).
- •Diets high in medium-chain triglyceride (MCT) oil.
- •Use of bile acids, bile acid uptake inhibitors, lipid-binding resins, synthetic fat substitutes (e.g. Olestra), and diaper rash ointments (note that H2 antagonists and proton pump inhibitors [PPIs] are permitted if on a stable and consistent regimen throughout the duration of the study).
- •History or presence of other concomitant liver diseases such as liver transplant rejection with cholestasis, hepatitis B or C virus infection, HIV, primary sclerosing cholangitis (PSC), alcoholic liver disease, autoimmune hepatitis, metabolic-associated fatty liver disease (MASLD)/non-alcoholic steatohepatitis (NASH) or significant chronic allograft rejection.
- •Currently pregnant or breastfeeding.
- •Cancers except for in situ carcinoma or cancers treated at least 5 years prior to screening with no evidence of recurrence.
- •Participation in a clinical trial and received an investigational product within the last 30 days.
- •Use of anti-diarrheal, anti-spasmodic, and/or cathartic laxatives. Change in osmotic laxatives within the past 3 months.
研究组 & 干预措施
All Participants
Experimental
干预措施: Fecal Fat (Diagnostic Test)
结局指标
主要结局
Dietary fat absorption
时间窗: At the completion of the 72-hour stool collection period
Dietary fat absorption is measured by calculating the percent of fat absorption (0-100%). Higher percentage of fat absorption indicates good fat absorption.
Improvement in dietary fat absorption
时间窗: End of the 4 week treatment period
Improvement in dietary fat absorption is measured by calculating the percent of fat absorption (0-100%). Higher percentage of fat absorption indicates improvement.
次要结局
未报告次要终点
研究者
研究点 (8)
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