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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00633191
Acronym
PseudIgY
Enrollment
14
Registered
2008-03-11
Start date
2003-11-30
Completion date
2012-12-31
Last updated
2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Infection, Pseudomonas Aeruginosa

Keywords

Cystic fibrosis, Prevention, Infection, Pseudomonas aeruginosa, Gargle

Brief summary

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

Detailed 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.

Interventions

DRUGAnti-pseudomonas IgY gargle

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

Sponsors

Immunsystem AB
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Egg allergy

Design outcomes

Primary

MeasureTime frame
Sputum culture positive for Pseudomonas aeruginosaProspective

Secondary

MeasureTime frame
Pulmonary functionProspective

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026