Clinical Trials Directory

Trials / Completed

CompletedNCT03554278

Alteration of Stool Microbiota in Preterm Infants With Anemia

Alteration of Stool Microbiota in Preterm Infants Less Than 32 Weeks With Anemia, and Following Blood Transfusion

Status
Completed
Phase
Study type
Observational
Enrollment
57 (actual)
Sponsor
University of Texas Southwestern Medical Center · Academic / Other
Sex
All
Age
7 Days – 30 Days
Healthy volunteers
Accepted

Summary

This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.

Detailed description

Necrotizing enterocolitis (NEC) is a leading cause of death in preterm infants, yet the disease mechanism is not well understood. Among the factors that have been studied are the change in stool microbiota (dysbiosis), severe anemia, and transfusion. Studies suggest that dysbiosis occurs in neonates with NEC. Large studies and meta-analyses have shown a predominance of Gammaproteobacteria, a decrease in Firmicutes, and decreased bacterial diversity in stool from infants with NEC. Studies do not support a relationship between transfusions and NEC since there are conflicting findings on this topic. There is a suggestion, however, that severe anemia may be associated with NEC though this requires further study. No studies have been done evaluating the relationship between anemia and change in stool microbiota, or blood transfusion and change in stool microbiota. This study aims to primarily evaluate the relationship between anemia and stool microbiota, and secondarily evaluate the relationship between transfusion and stool microbiota.

Conditions

Timeline

Start date
2018-10-09
Primary completion
2023-10-30
Completion
2023-10-30
First posted
2018-06-13
Last updated
2025-02-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03554278. Inclusion in this directory is not an endorsement.