NCT03576027Unknown不适用
Evaluation of the Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Inflammatory Bowel Disease in Children
Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of the ulcerative colitis activity
研究概览
简要总结
The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Crohn's disease or ulcerative colitis according to the criteria from Porto - based on the clinical condition as well as imaging and endoscopic examinations with histopathological assessment;
- •failure to achieve the remission despite the use of standard treatment in accordance with international guidelines;
- •written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.
排除标准
- •intolerance of enclosed spaces;
- •contraindications for hyperbaric therapy: otolaryngological (otitis media, sinusitis); cardiac (clinically significant defects or arrhythmias); pneumological (clinically significant defects)
- •exacerbation of inflammatory bowel disease during the therapy;
- •contraindications for hyperbaric therapy in a patient's caregiver in a situation, where the patient requires his/hers presence inside the hyperbaric chamber during the session.
结局指标
主要结局
Change of the ulcerative colitis activity
时间窗: 40 days
Change in the disease activity based on the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis.
Change of the Crohn's disease activity
时间窗: 40 days
Change in the disease activity based on the Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease.
次要结局
- Concentration of proinflammatory cytokines(40 days)
- Number of participants with treatment-related adverse events(40 days)
- Maintaining remission of the ulcerative colitis(1 year)
- Maintaining remission of the Crohn's disease(1 year)
研究者
Lukasz Dembinski
Principal Investigator
Medical University of Warsaw
研究点 (2)
Loading locations...
相似试验
终止
2 期
Efficacy of Hyperbaric Oxygen Therapy in the Treatment of OsteoradionecrosisOsteoradionecrosisNCT00989820Radboud University Medical Center20
Unknown
1 期
Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia PatientsPainTrigeminal NeuralgiaNCT00866424Xijing Hospital30
Unknown
不适用
The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating StrokeHyperbaric Oxygen TherapyStrokePneumoniaNCT04376359Ya Zhang168
已完成
不适用
The effectiveness of hyperbaric oxygen therapy (HBOT) for healing venous leg ulcersVenous leg ulcersCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemACTRN12611000505909Collaborate Sponsorship: Wesley Centre for Hyperbaric Medicine, Queensland University of Technology, and the Wound Management Innovation CRC84
已完成
2 期
The Effect of Hyperbaric Oxygen Therapy on Inflammatory Parameters Induced by a Heat Injury ModelSecondary HyperalgesiaInflammationNCT02397343Rigshospitalet, Denmark26