Alteration of Stool Microbiota in Preterm Infants With Anemia

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03554278
• Other study ID #: STU 092017-028
• Status: Active, not recruiting
• Start date: October 9, 2018
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: October 31, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Days to 30 Days

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Anemia, Neonatal
• Dysbiosis
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Locations

Country	Name	City	State
United States	Parkland Health & Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015. Erratum In: Front Pediatr. 2015;3:60. — View Citation

Hay S, Zupancic JA, Flannery DD, Kirpalani H, Dukhovny D. Should we believe in transfusion-associated enterocolitis? Applying a GRADE to the literature. Semin Perinatol. 2017 Feb;41(1):80-91. doi: 10.1053/j.semperi.2016.09.021. Epub 2016 Nov 17. — View Citation

Pammi M, Cope J, Tarr PI, Warner BB, Morrow AL, Mai V, Gregory KE, Kroll JS, McMurtry V, Ferris MJ, Engstrand L, Lilja HE, Hollister EB, Versalovic J, Neu J. Intestinal dysbiosis in preterm infants preceding necrotizing enterocolitis: a systematic review and meta-analysis. Microbiome. 2017 Mar 9;5(1):31. doi: 10.1186/s40168-017-0248-8. — View Citation

Patel RM, Denning PW. Intestinal microbiota and its relationship with necrotizing enterocolitis. Pediatr Res. 2015 Sep;78(3):232-8. doi: 10.1038/pr.2015.97. Epub 2015 May 20. — View Citation

Patel RM, Knezevic A, Shenvi N, Hinkes M, Keene S, Roback JD, Easley KA, Josephson CD. Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis in Very Low-Birth-Weight Infants. JAMA. 2016 Mar 1;315(9):889-97. doi: 10.1001/jama.2016.1204. — View Citation

Warner BB, Deych E, Zhou Y, Hall-Moore C, Weinstock GM, Sodergren E, Shaikh N, Hoffmann JA, Linneman LA, Hamvas A, Khanna G, Rouggly-Nickless LC, Ndao IM, Shands BA, Escobedo M, Sullivan JE, Radmacher PG, Shannon WD, Tarr PI. Gut bacteria dysbiosis and necrotising enterocolitis in very low birthweight infants: a prospective case-control study. Lancet. 2016 May 7;387(10031):1928-36. doi: 10.1016/S0140-6736(16)00081-7. Epub 2016 Mar 9. — View Citation

Warner BB, Tarr PI. Necrotizing enterocolitis and preterm infant gut bacteria. Semin Fetal Neonatal Med. 2016 Dec;21(6):394-399. doi: 10.1016/j.siny.2016.06.001. Epub 2016 Jun 22. — View Citation

Zhou Y, Shan G, Sodergren E, Weinstock G, Walker WA, Gregory KE. Longitudinal analysis of the premature infant intestinal microbiome prior to necrotizing enterocolitis: a case-control study. PLoS One. 2015 Mar 5;10(3):e0118632. doi: 10.1371/journal.pone.0118632. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	qRT-PCR (polymerase chain reaction) quantitative stool analysis	Quantify major bacterial groups, including Proteobacteria, Firmicutes, and Bacteroides in stool samples	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.
Secondary	Alpha diversity	Use next generation sequencing to assess changes in alpha diversity of bacteria between non-anemic and anemic stool samples	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.