Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections; Enterocolitis; Enterocolitis, Necrotizing; Premature Birth
Study type: Interventional

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.
    

Intervention name(s): use probiotics boucardii; use probiotics Multi-species
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Necrotizing enterocolitis; Probiotics; Secreting IgA; Preterm newborns