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Trial record 2 of 2 for:    IgY | Cystic Fibrosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633191
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : September 1, 2016
Information provided by (Responsible Party):
Immunsystem AB

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
Cystic Fibrosis Infection Pseudomonas Aeruginosa Drug: Anti-pseudomonas IgY gargle 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients
Study Start Date : November 2003
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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:
  • oral immunotherapy
  • Yolk antiboidies

Primary Outcome Measures :
  1. Sputum culture positive for Pseudomonas aeruginosa [ Time Frame: Prospective ]

Secondary Outcome Measures :
  1. Pulmonary function [ Time Frame: Prospective ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Egg allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00633191

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Cystic fibrosis centre,Children´s University Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Immunsystem AB
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Principal Investigator: Annika Hollsing, MD, PhD Uppsala Children´s University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Immunsystem AB Identifier: NCT00633191    
Other Study ID Numbers: Pseud-IgY-1
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Immunsystem AB:
Cystic fibrosis
Pseudomonas aeruginosa
Additional relevant MeSH terms:
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Cystic Fibrosis
Communicable Diseases
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections