Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decrease of laboratory markers of cholestasis
研究概览
简要总结
Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries. There are several lines of evidence that dietary gluten/gliadin displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes, irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective self-controlled mono-centric intervention study.
Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal inflammation in PSC and UC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(for PSC group):
- •Established diagnosis of PSC (based on radiologic features, typical finding on MRCP or ERCP)
- •Age 18 - 65 years
- •ALP 1,5x higher than ULN
- •Signed informed consent
排除标准
- •(for PSC group):
- •Patients on gluten-free diet
- •Patients with coeliac disease or wheat allergy
- •Liver transplant recipients
- •PSC/AIH overlap syndrome
- •Other causes of liver disease
- •Radiologic or clinical signs of decompensated liver cirrhosis
- •Advanced liver cirrhosis (MELD score ˃ 15)
- •Recurrent acute cholangitis or cholangiogenic sepsis in past 3 months
- •Use of antibiotics in past 3 months
- •History of malignancy
- •Pregnant women
- •Not signed informed consent
- •Inclusion criteria (for UC group):
- •Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings
- •Extension of affected colon > 15cm
- •Mayo score 0-4
- •Signed informed consent
- •Exclusion criteria (for UC group):
- •CMV, Clostridium difficile enterocolitis in past 3 months
- •Use of antibiotics in past 3 months
- •Patients with coeliac disease or wheat allergy
- •Patients on gluten-free diet
- •Pregnant women
- •Not signed informed consent
- •Biologic therapy
- •Methotrexate
- •Prednison > 10 mg
- •Not signed informed consent
结局指标
主要结局
Decrease of laboratory markers of cholestasis
时间窗: 6-12 months
Change of alkaline phosphatase \> 25% or normalisation.
Changes of intestinal microbiome composition.
时间窗: 6-12 months
16S-rRNA sequencing
次要结局
- Changes of morphological signs of intestinal inflammation(6-12 months)
- Improvement of quality of life and symptoms of ulcerative colitis.(6-12 months)
- Improvement of quality of life and symptoms of primary sclerosing cholangitis(6-12 months)
- Changes of histopathological signs of intestinal inflammation(6-12 months)
- Change from baseline of liver stiffness.(6-12 months)
研究者
Jan Březina
Senior consultant
Institute for Clinical and Experimental Medicine