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OpenTrials
Completed

NCT Number: NCT00633191

Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis

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

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Key information

Conditions

Cystic Fibrosis Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infection Infections Lung Diseases Pancreatic Diseases Pseudomonas Aeruginosa Pseudomonas Infections Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cystic fibrosis centre,Children´s University Hospital

Uppsala, SE-751 85, Sweden

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Egg allergy

Treatment and study plan

Anti-pseudomonas IgY gargle

Drug

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

Other names: oral immunotherapy, Yolk antiboidies

Primary outcomes

  1. Sputum culture positive for Pseudomonas aeruginosa

    Time frame: Prospective

Secondary outcomes

  1. Pulmonary function

    Time frame: Prospective

Sponsors and collaborators

Lead sponsor

Immunsystem AB

Other

Registry information

Official study title

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

Acronym: PseudIgY

Important dates

Study start
2003
Primary completion
2012
Study completion
2012
First posted
Mar 11, 2008
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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