PseudIgY: Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis
Study Details
Study Description
Brief Summary
Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will prevent infections with this bacteria in patients with Cystic fibrosis (CF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anti-pseudomonas IgY gargle Intervention: Gargles with anti-pseudomonas IgY every night |
Drug: Anti-pseudomonas IgY gargle
Gargle (solution), > 5FKU, every night after toothbrushing, life-long
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sputum culture positive for Pseudomonas aeruginosa [Prospective]
Secondary Outcome Measures
- Pulmonary function [Prospective]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical diagnosis of cystic fibrosis
-
Colonized with Pseudomonas aeruginosa
-
informed consent
Exclusion Criteria:
- Egg allergy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cystic fibrosis centre,Children´s University Hospital | Uppsala | Sweden | SE-751 85 |
Sponsors and Collaborators
- Immunsystem AB
Investigators
- Principal Investigator: Annika Hollsing, MD, PhD, Uppsala Children´s University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Carlander D, Kollberg H, Larsson A. Retention of specific yolk IgY in the human oral cavity. BioDrugs. 2002;16(6):433-7.
- Kollberg H, Carlander D, Olesen H, Wejåker PE, Johannesson M, Larsson A. Oral administration of specific yolk antibodies (IgY) may prevent Pseudomonas aeruginosa infections in patients with cystic fibrosis: a phase I feasibility study. Pediatr Pulmonol. 2003 Jun;35(6):433-40.
- Nilsson E, Amini A, Wretlind B, Larsson A. Pseudomonas aeruginosa infections are prevented in cystic fibrosis patients by avian antibodies binding Pseudomonas aeruginosa flagellin. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Sep 1;856(1-2):75-80. Epub 2007 Jun 2.
- Nilsson E, Hanrieder J, Bergquist J, Larsson A. Proteomic characterization of IgY preparations purified with a water dilution method. J Agric Food Chem. 2008 Dec 24;56(24):11638-42. doi: 10.1021/jf802626t.
- Nilsson E, Kollberg H, Johannesson M, Wejåker PE, Carlander D, Larsson A. More than 10 years' continuous oral treatment with specific immunoglobulin Y for the prevention of Pseudomonas aeruginosa infections: a case report. J Med Food. 2007 Jun;10(2):375-8.
- Nilsson E, Larsson A, Olesen HV, Wejåker PE, Kollberg H. Good effect of IgY against Pseudomonas aeruginosa infections in cystic fibrosis patients. Pediatr Pulmonol. 2008 Sep;43(9):892-9. doi: 10.1002/ppul.20875.
- Nilsson E, Stålberg J, Larsson A. IgY stability in eggs stored at room temperature or at +4°C. Br Poult Sci. 2012;53(1):42-6. doi: 10.1080/00071668.2011.646951.
- Pseud-IgY-1