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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-pseudomonas IgY gargle | Experimental | Intervention: Gargles with anti-pseudomonas IgY every night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-pseudomonas IgY gargle | Drug | Gargle (solution), > 5FKU, every night after toothbrushing, life-long |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sputum culture positive for Pseudomonas aeruginosa | Prospective |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function | Prospective |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annika Hollsing, MD, PhD | Uppsala Children´s University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cystic fibrosis centre,Children´s University Hospital | Uppsala | SE-751 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12463766 | Background | Carlander D, Kollberg H, Larsson A. Retention of specific yolk IgY in the human oral cavity. BioDrugs. 2002;16(6):433-7. doi: 10.2165/00063030-200216060-00004. | |
| 12746939 | Background | Kollberg H, Carlander D, Olesen H, Wejaker 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. doi: 10.1002/ppul.10290. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D007239 | Infections |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 17651078 | Background | Nilsson E, Kollberg H, Johannesson M, Wejaker 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. doi: 10.1089/jmf.2006.214. |
| 18680179 | Background | Nilsson E, Larsson A, Olesen HV, Wejaker 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. |
| 17581799 | Background | 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. doi: 10.1016/j.jchromb.2007.05.029. Epub 2007 Jun 2. |
| 19053374 | Background | 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. |
| 22404803 | Background | Nilsson E, Stalberg J, Larsson A. IgY stability in eggs stored at room temperature or at +4 degrees C. Br Poult Sci. 2012;53(1):42-6. doi: 10.1080/00071668.2011.646951. |
| 32671834 | Derived | Hurley MN, Smith S, Forrester DL, Smyth AR. Antibiotic adjuvant therapy for pulmonary infection in cystic fibrosis. Cochrane Database Syst Rev. 2020 Jul 16;7(7):CD008037. doi: 10.1002/14651858.CD008037.pub4. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |