Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics ((PEPP))

The Use of Probiotics (L. Acidophilus Boucardii vs. Multi-species) in the Prevention of Necrotizing Enterocolitis and Their Effect on Secreting IgA in the Feces of Premature Newborns Under Less Than 1500 g

The purpose of this study is to evaluate the incidence of necrotizing enterocolitis and its effect over the secreting immunoglobulin A in the feces with the use of probiotics of the strain Lactobacillus acidophilus boucardii vs. Multispecies in premature newborns weighting less than 1500 g.

Study Overview

• Status: Completed
• Conditions: Infectious Diseases
• Intervention / Treatment: Dietary supplement: use probiotics boucardii; Dietary supplement: use probiotics Multi-species

Detailed Description

Randomized controlled trial, in the Neonatal department of Highly Specialized Medical Unit (UMAE) of Hospital Pediatric - Gynecology No. 48 of Mexican Institute of Social Security (IMSS ) on Leon, Mexico, between 15th of December 2013 and 30th of October 2014, on premature newborns of less than 1500 g. They were two groups of patients:

Group A: was given Lacteol fort, which contains 1x10⁹(CFU) of Lactobacillus acidophilus strain boucardii every 24 hours during 3 weeks. Its presentation is a powder of 160 mg. It's manufactured by (Carnot ® laboratories), scientific products .

Group B: was given multispecies probiotic, which contains 1x10⁹ (CFU) of Lactobacillus acidophilus, rhamnosus, casei, plantarum, Bifidobacterium infantis, Streptococcus thermophilus , every 24 hours during 3 weeks. Its presentation is a powder with 1. (ITALMEX laboratories), scientific products .

All patients received trophic enteral stimulation for 5 days, then an increasing amount of 12-20 ml/kg of breast milk on a daily basis, according to the Clinical Practice Guidelines of feeding premature newborns of the investigators hospital.

The envelops containing the probiotic they were labeled with patient data and handled to the nurse in charge of the feeding so that it can be added preferably to the prescribed breast milk, and administered at12 o´clock every day with the feeding.

The diagnosis of Necrotizing Enterocolitis (NEC) was made by the attending physician using Bell criteria. Moreover the attending physician did the adjustments in the amount of breast milk consumed by the patient.

Gastric tolerance will be observed through: the presence of vomit, abdominal distention, presence of blood or bile juice on the gastric tube, and the pattern and characteristics of the feces using a daily record.Stool samples were taken between 9 am. and 21:00., before the first administration of probiotics and at the end of the third week of probiotic treatment. The samples were processed and frozen at -70'C. Quantifying secrete immunoglobulin A (IgA s) was made by immunodiagnostic assay K8870, Benshein, Germany ELISA.

was monitored the clinical evolution of Necrotizing Enterocolitis (NEC), medical or surgical treatment and the complications.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • University of Guanajuato School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All of the premature newborns of 34 weeks of gestational age, and with a weight between 700 to 1500 g. that are admitted in the Neonatal Intensive Care Unit or the Neonatology Department that have no contraindication for oral intake in the first 7 days of life. Must not have been diagnosed of sepsis of early onset, prenatal asphyxia, patent ductus arterious with hemodynamic repercussion, major congenital malformations. In all cases the parents or legal guardian must sign the informed consent.

Exclusion Criteria:

• All preterm newborns younger than 34 weeks of gestational age that develop any disease different of (NEC) that require to stop the enteral feeding for more than seven days or whose parents or legal guardians revoke the informed consent form.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: use probiotics boucardii; was administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks	Dietary supplement: use probiotics boucardii; group A was administered the lactobacillus acidophilus boucardii probiotic (1x10⁹ colonies forming units (UFC) per day for 3 weeks). The diagnosis of (NEC) was made using the Bell criteria by the attending physician. Gastric tolerance was measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) was measured at the beginning and at the end of treatment.
Experimental: use probiotics Multi-species; was administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks	Dietary supplement: use probiotics Multi-species; Group B was administered multi-species probiotic (1x10⁹colonies forming units (UFC) per day for 3 weeks). The diagnosis of (NEC) was made using the Bell criteria by the attending physician. Gastric tolerance was measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) was measured at the beginning and at the end of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With (NEC)	(NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III	3 weeks

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Investigators: Principal Investigator: Guadalupe Gómez Rodríguez, M.D., University of Guanjuato

Publications and helpful links

General Publications

• Gomez-Rodriguez G, Amador-Licona N, Daza-Benitez L, Barbosa-Sabanero G, Carballo-Magdaleno D, Aguilar-Padilla R, Gonzalez-Ramirez E. Single strain versus multispecies probiotic on necrotizing enterocolitis and faecal IgA levels in very low birth weight preterm neonates: A randomized clinical trial. Pediatr Neonatol. 2019 Oct;60(5):564-569. doi: 10.1016/j.pedneo.2019.02.005. Epub 2019 Mar 2.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 22, 2014

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Probiotics; Necrotizing enterocolitis; Preterm newborns; Secreting IgA
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infections; Communicable Diseases; Premature Birth; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: R-2013-1002-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED