Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization

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

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-18

Study Completion Date

2025-10-31

Brief Summary

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The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.

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Detailed Description

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Conditions

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Necrotizing Enterocolitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature neonates with necrotizing enterocolitis

Stool sample

Intervention Type OTHER

Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale

Premature neonates without necrotizing enterocolitis

Stool sample

Intervention Type OTHER

Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale

Interventions

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Stool sample

Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.
* Affiliated or beneficiary of a health insurance plan.
* Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.