The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis

Not Applicable

• Conditions: Death; Necrotizing Enterocolitis
• Interventions: Dietary Supplement: probiotics; Dietary Supplement: glucose solution

• Registration Number: NCT02552706
• Lead Sponsor: Shenzhen Bao'an Maternal and Child Health Hospital

Brief Summary

The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.

Detailed Description

Necrotizing enterocolitis (NEC) remains the most catastrophic gastrointestinal emergencies in preterm very low birth weight (VLBW) infants.Although study showed it is a multifactorial disease, its pathogenesis is still not yet unclear currently. Prematurity and formula feeding is considered as the main risk factors.Gut microbiota disturbance and immature immune system is associated with NEC. A lot of studies had showed that oral probiotics can alter gut microbiota flora colonization and reduce the incidence of NEC,but the exact mechanism remains unclear.The aim of this study is to elucidate the clinical efficacy and possible molecular mechanism of oral mixture probiotics in preventing NEC among preterm VLBW infants.

Patient Registry procedures: First,randomized numbers was generated by the computer and sent to the principal investigator(PI) at each center when an infant was eligible for enrollment.Second, patient will be assigned randomly to experimental group or control group by PI.Finally,the PI at each center will be responsible for the accuracy,completeness or representativeness of medical records, registry forms,data collection.

Sample size determination: The incidence of death and NEC was around 20% recently.To reduce the incidence of NEC and death to 10% at discharge would require a 50% improvement.At 80% power at P = 0.05 (two-sided),the loss rate of 0.2, this would require 135 subjects per arm.

Statistical analysis:The two groups were compared by a Χ2-test for categorical variables,Mann-Whitney U Test were used when reporting medians.A P value of \<0.05 was considered statistically significant.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-09
• Study First Submitted: 2015-09-12
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Last Update Submitted: 2016-03-26
• Last Update Posted: 2016-03-29
• Primary Completion: 2017-01
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Preterm infants ≦ 34 weeks gestational age and birth weight below 1500 gm and who survive to NICU are eligible for the trial.

Exclusion Criteria

• severe asphyxia (stage III),
• fetal chromosomal anomalies,
• cyanotic congenital heart disease,
• congenital intestinal atresia, gastroschisis, omphalocele, active upper gastric intestinal bleeding,
• lacking/refused of parental consent,
• those who are fasted for >3 weeks during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotics group	probiotics	Administration of probiotics 500mg begins by mouth within 4 hours of life with 1-3 consecutive doses; the frequency depends on the feeding times. Study is continuous until preterm infants grow up to 36 weeks post menstrual age.
control group	glucose solution	control group received 1 mL of a 5% glucose solution. Administration of control group begins by mouth within 4 hours of life with 1-3 consecutive doses; the frequency depends on the feeding times. Study is also continuous until preterm infants grow up to 36 weeks post menstrual age.

Primary Outcome Measures

Name	Time	Method
the incidence of combined death and necrotizing enterocolitis	at 36 weeks correct gestational age

Secondary Outcome Measures

Name	Time	Method
the incidence of sepsis,intraventricular hemorrhage(IVH)(grade 3-4),feeding intolerance(FI),bronchopulmonary dysplasia(BPD),parenteral nutrition associated liver disease(PNALD)and retinopathyof prematurity(ROP).	participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Trial Locations

Locations (4)

Longhua People's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

Shenzhen Bao'an Maternal and Child Health Hospital; 🇨🇳 Shenzhen, Guangdong, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Shenzhen Sixth People's Hospital; 🇨🇳 Shenzhen, Guangdong, China