Effect of Parabiotics As an Adjuvant in Nutritional Management of Pediatric Celiac Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life .
研究概览
简要总结
This is a sequential study to evaluate the effect of parabiotics as an adjuvant therapy with gluten restriction on quality of life in children with Celiac disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Celiac cases diagnosed either by non-biopsy approach {serology based: high IgA antibodies against transglutaminase ≥10 times the upper limit of normal with positive endomysial antibodies or diagnosed by biopsy using March classification
排除标准
- •Immunocompromised patients
- •Patients taking immunosuppressant drugs or antibiotics within the last 4 weeks or during the study
研究组 & 干预措施
Pediatric celiac patients
Strict gluten free food regimen for 3 weeks then parabiotics (Lacteolfort ®) added for another 3 weeks.
干预措施: Gluten free diet for 3 weeks then parabiotic (Lacteolfort®) for another 3 weeks (Other)
结局指标
主要结局
Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life .
时间窗: 3 weeks
Evaluate the effect of parabiotics as an adjuvant therapy to gluten free diet in celiac patients' quality of life using pediatric quality of life(PedsQL)Gastrointestinal symptoms module version 3.0. It has specific gastrointestinal symptom domains, scoring from 0-4 (0 indicates never a problem, 1 indicates almost never a problem, 2 indicates sometimes a problem, 3 indicates often a problem and 4 indicates almost always a problem) then cores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The higher the score is the better quality of life, there is no cutoff value for this score.
次要结局
未报告次要终点
研究者
Haya Essam Ibrahim
lecturer of pediatrics
Ain Shams University