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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| use probiotics boucardii | Experimental | was administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks |
|
| use probiotics Multi-species | Experimental | was administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guadalupe Gómez Rodríguez, M.D. | University of Guanjuato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guanajuato School of Medicine | León | Guanajuato | 37000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30898471 | Derived | 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. |
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clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With (NEC) | (NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III | Posted | Number | participants | 3 weeks |
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Use Probiotics Lactobacillus Acidophilus Boucardii | group A will be administered the lactobacillus acidophilus boucardii probiotic (1x109 colonies forming units (UFC) per day for 3 weeks). use probiotics Lactobacillus acidophilus boucardii: group A will be administered the Lactobacillus acidophilus 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. |
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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).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra. Guadalupe Gómez Rodríguez | Instituto Mexicano del Seguro Social | 477 75 23 166 | lupitaneonato@gmail.com |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | weeks of gestation |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| 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). | Posted | Geometric Least Squares Mean | 95% Confidence Interval | mg/10g | 3 weeks |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | 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. | 0 | 45 | 0 | 45 |
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| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |