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

Immunsystem AB

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infection; Cystic Fibrosis; Pseudomonas Aeruginosa

Treatments: Drug: Anti-pseudomonas IgY gargle

Study type: Interventional

Funder types: Other

Identifiers

NCT00633191

Pseud-IgY-1

Details and patient eligibility

About

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

Full description

"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.

Enrollment: 14 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Egg allergy

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Anti-pseudomonas IgY gargle

Experimental group

Description:

Intervention: Gargles with anti-pseudomonas IgY every night

Treatment:

Drug: Anti-pseudomonas IgY gargle