Development of Preterm Infant Gut Microbiome

Recruiting

• Conditions: Premature Infants
• Interventions: Other: No intervention

• Registration Number: NCT03552952
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature

Detailed Description

Preterm birth, defined as childbirth occurring at less than 37 completed weeks, is a major determinant of neonatal mortality and morbidity and has long-term adverse consequences for health. The human microbiome is the collective genome of the immense ecosystem of trillions of microbes and is considered to have a coevolved relationship with the immune system and fundamental roles in multiple aspects of human physiology. Little is known about the developmental of the gut microbiome in preterm infants as they grow and mature.

One hundred premature infants born in Rambam healthcare campus in Haifa, Israel, will be recruited to the study and 100 term healthy infants will be recruited as controls. Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study. Fecal samples will be collected during the hospital stay and in follow-up visits. Blood samples will be taken during the hospital stay. The investigators will analyze the data from this clinical cohort using computational and experimental approaches for extracting novel information on microbiome composition and development, gene function, metabolic pathways and metabolite production.

Study Timeline

• Study Start: 2018-03-08
• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-10
• Study First Posted: 2018-06-12
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-19
• Last Update Posted: 2020-07-22
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Premature and term infants born in Rambam healthcare campus in Haifa, Israel

Exclusion Criteria

• Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infants	No intervention	100 preterm infants
Term infants	No intervention	100 term healthy infants

Primary Outcome Measures

Name	Time	Method
Changes in gut microbial abundance over time	One year	Preterm infants and full-term infants fecal DNA at different time points

Trial Locations

Locations (1)

Department of Neonatology and Neonatal Intensive Carer unit Rambam medical center; 🇮🇱 Haifa, Israel