Effects of Lactobacillus Reuteri in Premature Infants

Premature Infant Disease Clinical Trial

— Reuteri  

Official title:

Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01181791
• Other study ID #: 20090924
• Status: Terminated
• Phase: N/A
• First received: August 2, 2010
• Last updated: August 24, 2017
• Start date: July 2010
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.

The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.

Description:

The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days

Exclusion Criteria:

• Chromosomal anomalies.

• Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)

• Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention

• Parental refusal

• Prior enrollment into a conflicting clinical trial

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Premature Birth
• Premature Infant Disease

Intervention

Dietary Supplement:
• Lactobacillus reuteri
Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day

Other:
• Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present.

Locations

Country	Name	City	State
Chile	Hospital Sotero del Rio	Santiago
Chile	Pontifica Universidad Catolica	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach full feeds	Days to reach full feeds from the day feeds are started	First 40 days after birth
Secondary	Intestinal colonization	PCR quantification of lactobacillus reuteri in the stools	0-6 months after birth
Secondary	Intestinal immunological response	Quantification immunological markers in the stools	0-6 months