The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis

March 26, 2016 updated by: liyuefeng, Shenzhen Bao'an Maternal and Child Health Hospital

The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis Among Very Low Birth Weight Infants With Formula-feeding

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518100
        • Active, not recruiting
        • Longhua People's Hospital of Shenzhen
      • Shenzhen, Guangdong, China, 518100
        • Recruiting
        • Shenzhen Bao'an Maternal and Child Health Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518100
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518100
        • Active, not recruiting
        • Shenzhen Sixth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: probiotics group
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.
Dietary supplement: probiotics
Administration of mixture probiotics 500mg by mouth, one time or divided into 2-4 times depends on the feeding volume until to 36 weeks post menstrual age.
Placebo Comparator: control group
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.
Dietary supplement: glucose solution
Administration of 1 mL of a 5% glucose solution by mouth, one time or divided into 2-4 times depends on the feeding volume until to 36 weeks post menstrual age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of combined death and necrotizing enterocolitis
Time Frame: at 36 weeks correct gestational age
at 36 weeks correct gestational age

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
participants will be followed for the duration of hospital stay, an expected average of 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the influence of oral probiotics on gut microbiota and immunomodulatory
Time Frame: at birth, 2 and 4 weeks of life, 36 week correct gestational age.
test fecal microbiota via high throughput sequencing and blood toll like receptor(TLR)2,TLR4,neclear factor kappa B(NF-KB)were detected using flow cytomtry.Inflammatory factors of blood were tested via Cytometric Bead Array(CBA).All above samples were obtained only from Shenzhen Bao'an Maternal and Child Health Hospital.The fecal DNA were first extracted at centre laboratory in aboved hospital and sent them to Beijing Genomics Institute(BGI) for further sequenceing ,if necessary, quantitative polymerase chain reaction(qPCR)of gut dominant bacterias related to late onset sepsis(LOS) will be tested for assessing the effect of oral probiotics on gut microbiota and underlying the mechanism. Flow cytometry analysis of TLR2,TLR4 and NF-KB were made by the senior laboratorian of our department and resposible for the accuracy of experimental result. CBA of inflammatory factors will be made by senting the blood samples to Beijing JIAMAY BIOLAB.
at birth, 2 and 4 weeks of life, 36 week correct gestational age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Bao'an Maternal and Child Health Hospital

Collaborators

China Medical University Hospital
Shenzhen People's Hospital
Shenzhen Sixth People's Hospital
Longhua Hospital Of Baoan District, Shenzhen

Investigators

  • Principal Investigator: Yuefeng Li, M.D., Shenzhen Bao'an Maternal and Child Health Hospital
  • Study Director: HungChih Lin, M.D., China Medical University Hospital
  • Study Director: Benqing Wu, M.D., Shenzhen People's Hospital
  • Study Director: Xiaodong Li, M.D., Shenzhen Sixth People's Hospital
  • Study Director: Zhangxin Wang, M.D., Longhua Hospital Of Baoan District, Shenzhen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 12, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 26, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LL2014006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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