Clinical trial NCT02552706: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis
Official title: The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis Among Very Low Birth Weight Infants With Formula-feeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotizing Enterocolitis
Death
Keywords: probiotics
preterm very low birth weight infants
necrotizing enterocolitis
gut microflora
TLR
NF-KB
inflammatory factors
Lead sponsor: Shenzhen Bao'an Maternal and Child Health Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University Hospital
name: Shenzhen People's Hospital
name: Shenzhen Sixth People's Hospital
name: Longhua Hospital Of Baoan District, Shenzhen
First posted: 2015-09-17
Enrollment: 270
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the incidence of combined death and necrotizing enterocolitis
timeFrame: at 36 weeks correct gestational age
Secondary outcomes:
measure: 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).
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Other outcomes:
measure: the influence of oral probiotics on gut microbiota and immunomodulatory
timeFrame: at birth, 2 and 4 weeks of life, 36 week correct gestational age.
Locations:
city: Shenzhen
country: China
facility: Longhua People's Hospital of Shenzhen
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Bao'an Maternal and Child Health Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Sixth People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Bao'an Maternal and Child Health Hospital
name: Yuefeng Li, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: HungChih Lin, M.D.
role: STUDY_DIRECTOR
affiliation: Shenzhen People's Hospital
name: Benqing Wu, M.D.
role: STUDY_DIRECTOR
affiliation: Shenzhen Sixth People's Hospital
name: Xiaodong Li, M.D.
role: STUDY_DIRECTOR
affiliation: Longhua Hospital Of Baoan District, Shenzhen
name: Zhangxin Wang, M.D.
role: STUDY_DIRECTOR
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