Infectious Diseases
Conditions
Keywords
Necrotizing enterocolitis, Probiotics, Secreting IgA, Preterm newborns
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.
Interventions
DIETARY_SUPPLEMENTuse 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.
DIETARY_SUPPLEMENTuse 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.
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
27 Weeks to 34 Weeks
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With (NEC) | 3 weeks | (NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III |
Countries
Mexico
Participant flow
Recruitment details
clinic
Participants by arm
| Arm | Count |
|---|---|
| Use Probiotics Boucardii group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
use probiotics Boucardii: group A will be administered the lactobacillus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment. | 45 |
| Use Probiotics Multi-species Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks).
use probiotics Multi-species: Group B will be administered multi-species probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). The diagnosis of NEC will be made using the Bell criteria by the attending physician. Gastric tolerance will be measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) will be measured at the beginning and at the end of treatment. | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Use Probiotics Multi-species | Use Probiotics Boucardii | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 45 Participants | 45 Participants | 90 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 31.1 weeks of gestation STANDARD_DEVIATION 2.3 | 30.3 weeks of gestation STANDARD_DEVIATION 1.83 | 30.7 weeks of gestation STANDARD_DEVIATION 1.8 |
| Region of Enrollment Mexico | 45 participants | 45 participants | 90 participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Number of Patients With (NEC)
(NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Probiotics Lactobacillus Acidophilus Boucardii | Number of Patients With (NEC) | 0 participants |
| Use Probiotics Multi-species | Number of Patients With (NEC) | 1 participants |
Post Hoc
Change in Fecal Secretory IgA Levels From Baseline to 3 Weeks of Probiotics Use.
The change was calculated from two time points (at 3 weeks of treatment minus baseline).
Time frame: 3 weeks
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Probiotics Lactobacillus Acidophilus Boucardii | Change in Fecal Secretory IgA Levels From Baseline to 3 Weeks of Probiotics Use. | 0.3 mg/10g |
| Use Probiotics Multi-species | Change in Fecal Secretory IgA Levels From Baseline to 3 Weeks of Probiotics Use. | 0.56 mg/10g |