Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants

NCT ID: NCT06161285

Last Updated: 2025-02-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-06

Study Completion Date

2026-04-30

Brief Summary

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Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.

Detailed Description

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Conditions

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Bronchiolitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe bronchiolitis

venous blood samples. Buccal, nasopharyngeal and rectal swabs

Sampling

Intervention Type OTHER

Single-time sampling of respiratory virus-infected children

Non-hospitalized bronchiolitis

Capillary blood samples. Buccal, nasopharyngeal and rectal swabs

Sampling

Intervention Type OTHER

Single-time sampling of respiratory virus-infected children

Bronchiolitis ihospitalized in ICU

Capillary blood samples. Buccal, nasopharyngeal and rectal swabs

No interventions assigned to this group

Interventions

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Sampling

Single-time sampling of respiratory virus-infected children

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants \<12 months
* With bronchiolitis during RSV epidemic season
* No chronic illness
* No bronchiolitis medical history
* Signed consent from parents or legal guardians

Exclusion Criteria

* Chronic respiratory illness
* Medical history of bronchiolitis or newborn asthma
* Treatment with immunosuppressants
* Patient with no social security affiliation
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Infectious Diseases Models for Innovative Therapies center

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Etienne BIZOT, Doctor

Role: PRINCIPAL_INVESTIGATOR

AP-HP Hôpital Antoine Beclere

Locations

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APHP, Antoine Béclère Hospital

Clamart, , France

Site Status RECRUITING

AP-HP,Raymond Poincaré Hospital

Garches, , France

Site Status RECRUITING

Réanimation médico-chirurgicale Necker

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Etienne BIZOT, Doctor

Role: CONTACT

33145374618

Facility Contacts

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Etienne BIZOT, Doctor

Role: primary

33145374618

Justine ZINI, Doctor

Role: primary

33147107880

Charlotte Collignon, Dr

Role: primary

Other Identifiers

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2023-A01688-37

Identifier Type: OTHER

Identifier Source: secondary_id

APHP231177

Identifier Type: -

Identifier Source: org_study_id

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