Alteration of Stool Microbiota in Preterm Infants With Anemia
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|ClinicalTrials.gov Identifier: NCT03554278|
Recruitment Status : Suspended (Covid-19)
First Posted : June 13, 2018
Last Update Posted : May 14, 2020
|Condition or disease|
|Anemia, Neonatal Necrotizing Enterocolitis Dysbiosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Alteration of Stool Microbiota in Preterm Infants Less Than 32 Weeks With Anemia, and Following Blood Transfusion|
|Actual Study Start Date :||October 9, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Stool samples from infants with anemia. Severe anemia defined as hematocrit less than 25%. Anemia defined as hematocrit greater than or equal to 25% and less than 30%.
Stool samples from infants without anemia. No anemia defined as hematocrit equal to or greater than 30%.
- qRT-PCR (polymerase chain reaction) quantitative stool analysis [ Time Frame: qRT-PCR will be analyzed for infant stool samples from enrollment until infants are 38 weeks corrected, or until they are discharged from the hospital. This time frame will be an average of 10 weeks per infant. ]Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples
- Alpha diversity [ Time Frame: Infant stool samples will be analyzed from enrollment until infants are 38 weeks corrected, or until they are discharged from the hospital. This time frame will be an average of 10 weeks per infant. ]Use next generation sequencing to assess changes in alpha diversity of bacteria between non-anemic and anemic stool samples
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554278
|United States, Texas|
|Parkland Health & Hospital System|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Julie Mirpuri Hathiramani, MD||UT Southwestern Medical Center|