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CompletedNCT01022944BOLEROUpdated Jun 1, 2021

Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens

An interventional study of With chronic middle ear effusion and Without chronic middle ear effusion in Chronic Serous Otitis Media, Simple or Unspecified, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Months to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Non-randomized
Ages
18 Months to 10 Years
Sex
All
01

Study summary

Rationale: Bacterial biofilms are defined as an assemblage of bacterial cells enclosed in a self-produced glycocalyx matrix. Adherence on surfaces, and resistance to both antibiotic treatments and host defenses are ones of the major clinical features of bacterial biofilms. Hence, biofilm formations represent a serious clinical problem: they persist in human tissues and play a role in a large number of chronic and resistant infections. It has been estimated that more than 65% of all human bacterial infections involve biofilms. Recently, the investigators have demonstrated the presence of mucosal bacterial biofilms in adenoid tissues removed during routine adenoidectomy. Bacterial biofilms were visualized using Confocal Laser Scanning Microscopy (CLSM) with a technique of double staining showing both the bacterial cells and the glycocalyx matrix. Although this study clearly established that adenoids tissues can harbour mucosal biofilms, the prevalence of 54% the investigators found suggested that some groups of children may contain more biofilm formations than others. In an effort to relate the findings of mucosal biofilm with the clinical presentation, the investigators have designed the present work to compare the prevalence of mucosal biofilms in adenoidectomy specimens in two groups: one group of children with chronic otitis media (COM) with effusion versus another group of children without any COM, having adenoids removed for chronic obstruction.

Read the detailed description

The aim of this case-control study is to compare the prevalence of biofilms formations in adenoid tissues of children with COM versus a control group without any COM.

Design: This is a monocentric, prospective, unrandomized case-control study comparing the prevalence of biofilm formations in adenoid tissues of two groups.

Clinical research study without direct medical benefit: during routine adenoidectomy, specimens are not used and thrown away. This study do not modify the common management of included children.

Number of subjects required: A considered approach of simple size calculation have been made using a method proposed by MIETINEN for Mc NEMAR Chi2 test. Simple size N=104 will allow 80% power to detect different of 20% (absolute), considering a total percentage of discordance pair at 30 %.

Expected results: a higher prevalence (30% estimation) of biofilm formations in group 1 in comparison with that in group 2 would be the first clinical research study bringing understanding of the role of adenoid tissues by harboring mucosal biofilms in otitis prone children.

02

Conditions studied

  • Chronic Serous Otitis Media, Simple or Unspecified

Keywords

  • Serous otitis media
  • Biofilm
  • Adenoidectomy
  • Chronic otitis media
03

In context

Otitis

246 studies on the registry are indexed under Otitis; 21 are open to participants now.

This study's enrollment of 113 is below the median of 126 across 173 interventional studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Group 1 and 2

    • obtained informed consent by both parents and child (if possible),
    • age > 18 months and \<10 years
    • chronic serous otitis media lasting more than 3 months (group 1).
  • Group 1 only:

    • chronic secretory otitis media
  • Group 2 only:

    • hypertrophia adenoid vegetations without sinusal oropharyngeal infections

Exclusion criteria

Exclusion criteria:

  • No informed consent
  • age \< 18 months or > 10 years
  • Eustachian tube dysfunction
  • Immunodeficiency
  • Tumor
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
113 participants (actual)

Study arms

  • Other
    Group 2 :

    Children without chronic middle ear effusion as a control group having adenoids removed for chronic obstruction.

    Procedure: Without chronic middle ear effusion

  • Other
    Group 1

    Children with chronic middle ear effusion having adenoidectomy.

    Procedure: With chronic middle ear effusion

Interventions

  • ProcedureWith chronic middle ear effusion

    Children with chronic middle ear effusion having adenoidectomy.

  • ProcedureWithout chronic middle ear effusion

    Children without chronic middle ear effusion as a control group having adenoids removed for chronic obstruction.

06

What researchers measure

Primary outcomes

  1. Prevalence of mucosal biofilm formations in adenoidectomy specimens analyzed using Confocal Laser Scanning Microscopy with double staining

    Time frame: at 2 years

Secondary outcomes

  1. To build up a tissue bank of human tissue from adenoids and the middle ear for further bacterial identification

    Time frame: during the study

07

Study locations

1 site
  • Hôpital ROBERT DEBRE - ORL Pédiatrique
    Paris, 75020, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01022944
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Dec 1, 2009
Start date
Jul 2010
Primary completion
May 2012
Completion
May 2012
Last update
Jun 1, 2021

Study contacts

Romain KANIA, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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