Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Reduction of intestinal inflammatory activity
研究概览
简要总结
Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation.
Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves).
Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver.
Proof of hypothesis:
- Pilot study with n=20 patients with PSC
- Explorative, open-label, mono-centric study
- Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.
排除标准
- •patients with coeliac disease or wheat allergy
- •patients with active colitis
- •patients already on gluten-free diet
- •liver transplanted patients
- •patients also diagnosed with autoimmune hepatites (PSC-AIH overlap)
- •coloscopy within 2 months before study
- •Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study
- •antibiotics within 3 month before study
结局指标
主要结局
Reduction of intestinal inflammatory activity
时间窗: 2 months
Expression of pro-inflammatory cytokines in gut mucosa (Sigma)
次要结局
- Changes in patients microbiota(2 months (5 months with follow-up))
- Inflammatory activity of the liver(2 months)
- Reduction of inflammatory cells/markers in the blood(2 months)
- Quality of life(2 months)
- Change of symptoms with change of diet.(2 months)
研究者
Marcus Tetzlaff
study coordinator
Universitätsklinikum Hamburg-Eppendorf