Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics

NCT02226263 | Completed Phase 2

• 1 other identifier: R-2010-1002-12
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to know the effects of probiotics on the incidence of Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.

Conditions

Infectious Diseases

Keywords

Necrotizing enterocolitis; Probiotics; Preterm newborns

Outcome Measures

Primary Outcomes (1)

• Incidence of severe necrotizing enterocolitis in preterm newborns <1500g

  Group A received enteral stimulation trophic five days and later increments 20ml/k/day of breast milk or formula for premature; the group B apart from the above the probiotic Lactobacillus boucardii 1 X109 (CFU) / day for 4 weeks was added.

  23 month

Secondary Outcomes (1)

• Adverse effects with probiotic use in preterm newborns <1500g.

  23 month

Other Outcomes (1)

• Diagnosis the Necrotizing Enterocolitis (NEC)

  23 month

Study Arms (1)

probiotics Lactobacillus acidophilus boucardii strain.

EXPERIMENTAL

Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks .The probiotic presentation used was powder in an envelope with 160mg (Carnot ® Laboratories), scientific products, Mexico, (Registration Number 274M91SSA). This was stored in a dry place at room temperature, avoiding sunlight.

Dietary Supplement: probiotics Lactobacillus acidophilus boucardii

Interventions

probiotics Lactobacillus acidophilus boucardii DIETARY_SUPPLEMENT

Using sterile technique, the probiotic with 1x109 \[CFU\] Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants.

Also known as: Gastric tolerance, characteristics of discharges, evolution, reason for discharge, and the development of NEC was monitored.

probiotics Lactobacillus acidophilus boucardii strain.

Eligibility Criteria

• Age: 27 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• We studied 150 preterm newborns \<1500gr who were recruited on the day that began enteral feeding according to the decision of the treating physician.

You may not qualify if:

• Preterm infants \> 1500g with Apgar score \<6 at 5 minutes, gastrointestinal malformations, fetopathies, patent ductus arteriosis with hemodynamic decompensation, asphyxia, and NEC suspected as classified by Bell were excluded from the study.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Instituto Mexicano del seguro social

León, Guanajuato, 37000, Mexico

Location

MeSH Terms

Conditions

Communicable Diseases; Enterocolitis, Necrotizing

Interventions

Biological Evolution; Drainage

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena; Biological Phenomena; Therapeutics; Surgical Procedures, Operative

Study Officials

• Guadalupe Gómez, M.D.

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: neonatologist

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: August 27, 2014
• Study Start: March 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 27, 2014

Record last verified: 2014-08

Locations

ME (1)