Skip to main content
OpenTrials
Completed

NCT Number: NCT01022944

Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Serous Otitis Media, Simple or Unspecified Charcot-Marie-Tooth disease, Type 1C Ear Diseases Otitis Otitis Media Otitis Media with Effusion Otorhinolaryngologic Diseases

Age range

18 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital ROBERT DEBRE - ORL Pédiatrique

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

With chronic middle ear effusion

Procedure

Children with chronic middle ear effusion having adenoidectomy.

Without chronic middle ear effusion

Procedure

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

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens. A Case Control Study

Acronym: BOLERO

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2009
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.