Alteration of Stool Microbiota in Preterm Infants With Anemia

Active, not recruiting

• Conditions: Anemia, Neonatal; Dysbiosis; Necrotizing Enterocolitis

• Registration Number: NCT03554278
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-13
• Study Start: 2018-10-09
• Primary Completion: 2023-10-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 118

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
qRT-PCR (polymerase chain reaction) quantitative stool analysis	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

Secondary Outcome Measures

Name	Time	Method
Alpha diversity	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

Trial Locations

Locations (1)

Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States