Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis (PseudIgY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633191
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : September 1, 2016
Information provided by (Responsible Party):
Immunsystem AB

March 4, 2008
March 11, 2008
September 1, 2016
November 2003
December 2012   (Final data collection date for primary outcome measure)
Sputum culture positive for Pseudomonas aeruginosa [ Time Frame: Prospective ]
Same as current
Complete list of historical versions of study NCT00633191 on Archive Site
Pulmonary function [ Time Frame: Prospective ]
Same as current
Not Provided
Not Provided
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
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.
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Cystic Fibrosis
  • Infection
  • Pseudomonas Aeruginosa
Drug: Anti-pseudomonas IgY gargle
Gargle (solution), > 5FKU, every night after toothbrushing, life-long
Other Names:
  • oral immunotherapy
  • Yolk antiboidies
Experimental: Anti-pseudomonas IgY gargle
Intervention: Gargles with anti-pseudomonas IgY every night
Intervention: Drug: Anti-pseudomonas IgY gargle

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Egg allergy
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Not Provided
Plan to Share IPD: No
Immunsystem AB
Immunsystem AB
Not Provided
Principal Investigator: Annika Hollsing, MD, PhD Uppsala Children´s University Hospital
Immunsystem AB
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP