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

NCT ID: NCT02245815

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

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.

Conditions

Infectious Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

use probiotics boucardii

was administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks

Group Type: EXPERIMENTAL

use probiotics boucardii

Intervention Type: DIETARY_SUPPLEMENT

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.

use probiotics Multi-species

was administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks

Group Type: EXPERIMENTAL

use probiotics Multi-species

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 27 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Guadalupe Gómez Rodríguez

neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guadalupe Gómez Rodríguez, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Guanjuato

Locations

University of Guanajuato School of Medicine

León, Guanajuato, Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 30898471 (View on PubMed)

Other Identifiers

R-2013-1002-7

Identifier Type: -

Identifier Source: org_study_id