NCT00633191

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

9.1 years

First QC Date

March 4, 2008

Last Update Submit

August 31, 2016

Conditions

Cystic FibrosisInfectionPseudomonas Aeruginosa

Keywords

Cystic fibrosisPreventionInfectionPseudomonas aeruginosaGargle

Outcome Measures

Primary Outcomes (1)

  • Sputum culture positive for Pseudomonas aeruginosa

    Prospective

Secondary Outcomes (1)

  • Pulmonary function

    Prospective

Study Arms (1)

Anti-pseudomonas IgY gargle

EXPERIMENTAL

Intervention: Gargles with anti-pseudomonas IgY every night

Drug: Anti-pseudomonas IgY gargle

Interventions

Anti-pseudomonas IgY gargleDRUG

Gargle (solution), \> 5FKU, every night after toothbrushing, life-long

Also known as: oral immunotherapy, Yolk antiboidies
Anti-pseudomonas IgY gargle

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Egg allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cystic fibrosis centre,Children´s University Hospital

Uppsala, SE-751 85, Sweden

Location

Related Publications (8)

  • 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.

    PMID: 12463766BACKGROUND

  • 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.

    PMID: 12746939BACKGROUND

  • 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.

    PMID: 17651078BACKGROUND

  • 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.

    PMID: 18680179BACKGROUND

  • 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.

    PMID: 17581799BACKGROUND

  • 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.

    PMID: 19053374BACKGROUND

  • 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.

    PMID: 22404803BACKGROUND

  • 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.

    PMID: 32671834DERIVED

MeSH Terms

Conditions

Cystic FibrosisInfectionsPseudomonas Infections

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Annika Hollsing, MD, PhD

    Uppsala Children´s University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 11, 2008

Study Start

November 1, 2003

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

September 1, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)