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Completed

NCT Number: NCT03554278

Alteration of Stool Microbiota in Preterm Infants With Anemia

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2018
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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