ACTRN12613001210763招募中3 期
Effects of a four food elimination diet in children with eosinophilic oesophagitis – a multi-centre, randomised controlled trial and investigation of novel disease mechanisms
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Years 至 18 Years（—）
- 性别
- All
入选标准
- •Stage 1: All patients with possible EOE (age 1-18 yrs) undergoing a diagnostic gastroscopy at any of the four participating hospitals (at Royal Children’s Hospital Melbourne, Monash Medical Centre Melbourne, Children’s Hospital at Westmead Sydney, and Women’s and Children’s Hospital Adelaide) will be assessed for inclusion in the study.
- •Patients undergoing a diagnostic gastroscopy will be assessed for upper gastrointestinal symptoms, including:
- •* Nausea and vomiting
- •* Abdominal pain
- •* Diarrhoea
- •* FFT/weight loss
- •* Dysphagia
- •* Regurgitation
- •* Food bolus obstruction
- •* Food refusal
- •Stage 2: Patients will be inclucded in the randomised trial if a diagnosis of EOE was confirmed based on biopsies from the first gastroscopy. Biospies will be analysed by the hospital’s anatomical pathologist to assess whether the diagnostic criteria for EOE is confirmed. The diagnosis of EOE is based on the presence of at least 20 mucosal eosinophils/HPF in any of the upper or lower oesophageal biopsies.
- •NB: Patients who are already avoiding a food prior to the study as part of a known food allergy (e.g. egg or peanut allergy) can still be considered for the study if EOE was diagnosed while avoiding the food (which suggests that the food is not causing the EOE).
排除标准
- •Participants meeting the following criteria will be excluded from the study.
- •*The patient does not fulfil the histological criteria for EOE (less than 20 mucosal eosinophils/HPF on histology).
- •* Recent treatment with systemic corticosteroids (prednisolone) or topical or inhaled corticosteroids (fluticasone aerosol or viscous budesonide) within 3 months of the gastroscopy.
- •* Recent or current treatment with omeprazole.
- •* Patient already on multiple food elimination diet
- •* Previous failure of elimination diets (as it may skew the data towards non-response)
- •* Inability to obtain informed consent
- •* Inability to comply with the prescribed four-food elimination diet or PPI treatment
- •* Contraindications to gastroscopy or general anaesthesia
研究者
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