CLINICAL MANAGEMENT OF CHILDHOOD INTESTINAL LYMPHOID NODULAR HYPERPLASIA: A RANDOMIZED CONTROLLED CLINICAL TRIAL.
试验速览
- 阶段
- 4 期
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
Aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the clinical outcome of patients Methods.We recruited children who undergone diagnostic colonoscopy in Umberto I Pediatric Department (Rome, Italy) from 2008 to 2010. Eligibility criteria were: 1) only demonstration of LNH; 2) no concomitant disease; 3) no treatment assumed since the clinical onset. Patients were allocated 1:1:1 to dietetic (Group A) vs mesalamine (Group B) vs no treatment (Group C) for a 8-weeks period. Skin prick tests and patch test for common foods, and symptoms scoring at baseline and follow up have been performed by blinded clinicians. Chi-square test for trend was used to compare the frequency of symptoms score improvement (>1 point) among groups. The association of baseline features of patients with the clinical response was estimated by frequency analysis.
详细描述
Lymphoid nodular hyperplasia (LNH) of the lower gastrointestinal tract is a common finding in pediatric colonoscopies, whose clinical significance is not yet been clearly established. Although initially considered to be a normal, age-related variant, some authors recently suggested to regard LNH as a marker of food allergy (FA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated finding of LNH[18], defined as the demonstration of a significant cluster of lymphoid nodules (>10/visible field) by endoscopy and lymphoid follicle hyperplasia by hystology;
- •negative results of preliminary evaluation
排除标准
- •diagnosis of concomitant inflammatory, rheumatic or infectious disease, and
- •the assumption of any dietetic or therapy since the clinical onset.
研究组 & 干预措施
Mesalamine
A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects
干预措施: Mesalamine (Drug)
DIET
Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists
干预措施: DIET (Behavioral)
结局指标
主要结局
Efficacy
时间窗: 8 weeks
to identify an appropriate management approach for LNH by evaluation of clinical severity and response. Clinical severity at time 0 and 1 was assessed by Pediatric Gastroenterologists blinded to allocation concealment. Basing on standardized Childhood behaviour checklists questionaire compiled by parents, symptoms were graded using a validated score of abdominal pain (from 0 to 12). Clinical response was defined as the improvement of at least 1 point in symptom scores from time 0 to 1.
次要结局
- predictive factors(8 weeks)
研究者
Giovanni Di Nardo
MD
Azienda Policlinico Umberto I