Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis
NCT ID: NCT00633191
Last Updated: 2016-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2003-11-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Anti-pseudomonas IgY gargle
Intervention: Gargles with anti-pseudomonas IgY every night
Anti-pseudomonas IgY gargle
Gargle (solution), \> 5FKU, every night after toothbrushing, life-long
Interventions
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Anti-pseudomonas IgY gargle
Gargle (solution), \> 5FKU, every night after toothbrushing, life-long
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Colonized with Pseudomonas aeruginosa
* informed consent
Exclusion Criteria
ALL
No
Sponsors
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Immunsystem AB
OTHER
Responsible Party
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Principal Investigators
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Annika Hollsing, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala Children´s University Hospital
Locations
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Cystic fibrosis centre,Children´s University Hospital
Uppsala, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Pseud-IgY-1
Identifier Type: -
Identifier Source: org_study_id
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