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Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis (PseudIgY)

Primary Purpose

Cystic Fibrosis, Infection, Pseudomonas Aeruginosa

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Anti-pseudomonas IgY gargle
Sponsored by
Immunsystem AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystic Fibrosis focused on measuring Cystic fibrosis, Prevention, Infection, Pseudomonas aeruginosa, Gargle

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Egg allergy

Sites / Locations

  • Cystic fibrosis centre,Children´s University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti-pseudomonas IgY gargle

Arm Description

Intervention: Gargles with anti-pseudomonas IgY every night

Outcomes

Primary Outcome Measures

Sputum culture positive for Pseudomonas aeruginosa

Secondary Outcome Measures

Pulmonary function

Full Information

First Posted
March 4, 2008
Last Updated
August 31, 2016
Sponsor
Immunsystem AB
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1. Study Identification

Unique Protocol Identification Number
NCT00633191
Brief Title
Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis
Acronym
PseudIgY
Official Title
Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunsystem AB

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Infection, Pseudomonas Aeruginosa
Keywords
Cystic fibrosis, Prevention, Infection, Pseudomonas aeruginosa, Gargle

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-pseudomonas IgY gargle
Arm Type
Experimental
Arm Description
Intervention: Gargles with anti-pseudomonas IgY every night
Intervention Type
Drug
Intervention Name(s)
Anti-pseudomonas IgY gargle
Other Intervention Name(s)
oral immunotherapy, Yolk antiboidies
Intervention Description
Gargle (solution), > 5FKU, every night after toothbrushing, life-long
Primary Outcome Measure Information:
Title
Sputum culture positive for Pseudomonas aeruginosa
Time Frame
Prospective
Secondary Outcome Measure Information:
Title
Pulmonary function
Time Frame
Prospective

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of cystic fibrosis Colonized with Pseudomonas aeruginosa informed consent Exclusion Criteria: Egg allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annika Hollsing, MD, PhD
Organizational Affiliation
Uppsala Children´s University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cystic fibrosis centre,Children´s University Hospital
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12463766
Citation
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.
Results Reference
background
PubMed Identifier
12746939
Citation
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.
Results Reference
background
PubMed Identifier
17651078
Citation
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.
Results Reference
background
PubMed Identifier
18680179
Citation
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.
Results Reference
background
PubMed Identifier
17581799
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. doi: 10.1016/j.jchromb.2007.05.029. Epub 2007 Jun 2.
Results Reference
background
PubMed Identifier
19053374
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.
Results Reference
background
PubMed Identifier
22404803
Citation
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.
Results Reference
background
PubMed Identifier
32671834
Citation
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.
Results Reference
derived

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Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis

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