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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00633191
Other study ID # Pseud-IgY-1
Secondary ID
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


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
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