Alteration of Stool Microbiota in Preterm Infants With Anemia



Status:Recruiting
Conditions:Colitis, Anemia, Gastrointestinal
Therapuetic Areas:Gastroenterology, Hematology
Healthy:No
Age Range:Any
Updated:2/8/2019
Start Date:October 9, 2018
End Date:June 30, 2019
Contact:Kshiti D Shah, MD
Email:kshiti.shah@utsouthwestern.edu
Phone:703-999-7572

Use our guide to learn which trials are right for you!

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

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

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.

Inclusion Criteria:

- Preterm infants less than 32 weeks gestation at birth

- Age at enrollment between 7 days and less than/equal to 30 days

- Minimum 100 mL/kg/day enteral feeds

Exclusion Criteria:

- Development of necrotizing enterocolitis (NEC) prior to enrollment

- Prior surgery

- Major congenital anomalies

- Oxygen requirement with FiO2 (fraction of inspired oxygen) >50% (at time of
enrollment)
We found this trial at
1
site
Dallas, Texas 75235
Principal Investigator: Julie Mirpuri Hathiramani, MD
?
mi
from
Dallas, TX
Click here to add this to my saved trials