Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— PseudIgY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633191
• Other study ID #: Pseud-IgY-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 4, 2008
• Last updated: August 31, 2016
• Start date: November 2003
• Est. completion date: December 2012

Study information

• Verified date: August 2016
• Source: Immunsystem AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of cystic fibrosis

• Colonized with Pseudomonas aeruginosa

• informed consent

Exclusion Criteria:

• Egg allergy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Cystic Fibrosis
• Fibrosis
• Infection
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Drug:
• Anti-pseudomonas IgY gargle
Gargle (solution), > 5FKU, every night after toothbrushing, life-long

Locations

Country	Name	City	State
Sweden	Cystic fibrosis centre,Children´s University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Immunsystem AB

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

Carlander D, Kollberg H, Larsson A. Retention of specific yolk IgY in the human oral cavity. BioDrugs. 2002;16(6):433-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum culture positive for Pseudomonas aeruginosa		Prospective	Yes
Secondary	Pulmonary function		Prospective	Yes