Effect of a Cocktail of Two Common Enzyme Supplements on Celiac Disease Patients With Persistent Seropositivity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
研究概览
简要总结
The purpose of this study is to examine whether a cocktail of two common food-grade enzyme supplements leads to decrease of serum activity markers in celiac disease patients insufficiently treated by previous gluten exclusion.
详细描述
Celiac disease is genetically determined abnormal immune response to gluten, a component of wheat, rye and barley proteins that cause damage to the villous structure in the small bowel. The active disease is characterized by the induction of gluten-dependent autoantibodies to transglutaminase type-2, which are sensitive and specific non-invasive markers of gluten-sensitivity. Gluten-free diet normally leads to clearance of antibodies from serum in 6-12 months. Persistent seropositivity is a problem in patients who only incompletely exclude gluten or frequently transgress the diet. In such cases, damage of the small bowel may persist and complications may occur at higher frequency. The central hypothesis to be tested is that enzyme treatment designed to degrade a certain amount of gluten before absorption in the gastrointestinal tract will lead to a clinically meaningful decrease in auto-antibody levels in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Celiac disease diagnosed by small intestinal biopsy
- •More than 12 months elapsed since initial diagnosis and start of the dietary treatment
- •Evidence for ongoing active disease as verified by seropositivity or dermatitis herpetiformis rash
- •Subject agrees to follow a gluten-free diet
排除标准
- •Other gastrointestinal or hepatic disease besides celiac disease
- •Selective IgA deficiency
- •Use of dapsone or diaphenylsulfone
- •Pregnancy and breast-feeding
研究组 & 干预措施
Enzyme treatment
Enzyme for 12 weeks
干预措施: STAN1 (Drug)
Placebo control
Placebo enzyme for 12 weeks
干预措施: Placebo enzyme (Drug)
Enzyme + gluten
Enzyme and 500 mg gluten b.i.d. for 12 weeks
干预措施: STAN1+gluten (Drug)
结局指标
主要结局
Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
时间窗: 12 weeks
次要结局
- Negative conversion for celiac antibodies in the blood by the rapid test(12 weeks)
- Change in symptoms or rash (if any)(12 weeks)
- Favorable changes in morphometry in small bowel biopsy specimens(28 weeks)
- Negative seroconversion or drop of at least two dilution steps in the EMA test(12 weeks)
研究者
Ilma R Korponay-Szabo
Professor
Heim Pal Children's Hospital