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

NCT02245815 | Completed Results

• 1 other identifier: R-2013-1002-7
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Diseases

Keywords

Necrotizing enterocolitis; Probiotics; Secreting IgA; Preterm newborns

Outcome Measures

Primary Outcomes (1)

• Number of Patients With (NEC)

  (NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III

  3 weeks

Study Arms (2)

use probiotics boucardii

EXPERIMENTAL

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

Dietary Supplement: use probiotics boucardii

use probiotics Multi-species

EXPERIMENTAL

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

Dietary Supplement: use probiotics Multi-species

Interventions

use probiotics boucardii 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 boucardii

use probiotics Multi-species 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.

use probiotics Multi-species

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

University of Guanajuato School of Medicine

León, Guanajuato, 37000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 30898471 DERIVED

MeSH Terms

Conditions

Communicable Diseases; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The quantification of the amount of breast milk administered was imprecise because in the Unit there is no Milk Bank, and the visits from the mothers are restricted, however we acknowledge the crucial role of breast milk in the prevention of (NEC).

Results Point of Contact

• Title: Dra. Guadalupe Gómez Rodríguez
• Organization: Instituto Mexicano del Seguro Social

lupitaneonato@gmail.com

477 75 23 166

Study Officials

• Guadalupe Gómez Rodríguez, M.D.

  University of Guanjuato

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: neonatologist

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 22, 2014
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Locations

ME (1)