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临床试验/NCT00633191
NCT00633191已完成1 期

Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients

Immunsystem AB1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2003年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
Sputum culture positive for Pseudomonas aeruginosa

研究概览

简要总结

Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will prevent infections with this bacteria in patients with Cystic fibrosis (CF).

详细描述

"Anti-pseudomonas IgY" is prepared from eggs of hens that have been vaccinated with Pseudomonas aeruginosa. The hens farm is under veterinary control according to Swedish rules. The drug is prepared with a water dilution method according to GMP standards (approved by Swedish MPA). Patients with CF who are intermittently but not chronically infected with P. aeruginosa get a short course of antibiotics to eradicate the bacteria. Thereafter they start to gargle with a solution of "anti-pseudomonas IgY" every night to prevent a new infection. Preliminary results have shown that it takes a significantly longer time to get a new infection and that the patients get fewer infections than control patients. In addition, results tentatively indicate that: patients have not got any new opportunistic bacteria or fungi (B. Cepacia, S. Maltophilia, A. Xylosoxidans, atypical Mycobacteria, Aspergillus Fumigatus); that use of antibiotics is greatly diminished; that the lung functions and nutritional conditions are maintained.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of cystic fibrosis
  • Colonized with Pseudomonas aeruginosa
  • informed consent

排除标准

  • Egg allergy

研究组 & 干预措施

Anti-pseudomonas IgY gargle

Experimental

Intervention: Gargles with anti-pseudomonas IgY every night

干预措施: Anti-pseudomonas IgY gargle (Drug)

结局指标

主要结局

Sputum culture positive for Pseudomonas aeruginosa

时间窗: Prospective

次要结局

  • Pulmonary function(Prospective)

研究者

发起方
Immunsystem AB
申办方类型
Other
责任方
Sponsor

研究点 (1)

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