Development of Preterm Infant Gut Microbiome

Premature Infants Clinical Trial

Official title:

Development of Preterm Infant Gut Microbiome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552952
• Other study ID #: 0490-17-RMB CTIL
• Status: Recruiting
• Start date: March 8, 2018
• Est. completion date: July 2025

Study information

• Verified date: July 2020
• Source: Rambam Health Care Campus
• Contact: Smadar Shilo, MD
• Phone: +972-7774400
• Email: smadar.shilo[@]weizmann.ac.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Premature Infants

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Israel	Department of Neonatology and Neonatal Intensive Carer unit Rambam medical center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gut microbial abundance over time	Preterm infants and full-term infants fecal DNA at different time points	One year