Trial | NCT00633191  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pseudigy ...

  • Study Participants

    14
Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will prevent infections with this bacteria in patients with Cystic fibrosis (CF).
"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.
Study Started
Nov 30
2003
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
Sep 01
2016
Estimate

Drug Anti-pseudomonas IgY gargle

Gargle (solution), > 5FKU, every night after toothbrushing, life-long

  • Other names: oral immunotherapy, Yolk antiboidies

Anti-pseudomonas IgY gargle Experimental

Intervention: Gargles with anti-pseudomonas IgY every night

Criteria 

Inclusion Criteria:

Clinical diagnosis of cystic fibrosis
Colonized with Pseudomonas aeruginosa
informed consent

Exclusion Criteria:

Egg allergy
No Results Posted