Infectious Diseases(PEPP)NCT02245815
Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics
A study testing use probiotics boucardii and use probiotics Multi-species in people with Infectious Diseases, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 27 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- use probiotics boucardii and use probiotics Multi-species
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
University of Guanajuato School of Medicine
León, Guanajuato, 37000
About this study
Official title: The Use of Probiotics (L. Acidophilus Boucardii vs. Multi-species) in the Prevention of Necrotizing Enterocolitis and Their Effect on Secreting IgA in the Feces of Premature Newborns Under Less Than 1500 g
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.
Read the 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
- Being tested
- use probiotics boucardii, use probiotics Multi-species
- Keywords
- Necrotizing enterocolitis, Probiotics, Secreting IgA, Preterm newborns
- Medical subject headings
- Communicable Diseases, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use probiotics boucardiiDietary 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-speciesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| use probiotics boucardii | Experimental | was administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks Receives: Dietary Supplement: use probiotics boucardii |
| use probiotics Multi-species | Experimental | was administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks Receives: Dietary Supplement: use probiotics Multi-species |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With (NEC)
(NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Guadalupe Gómez Rodríguez, Coordinación de Investigación en Salud, Mexico
- Investigators
- Guadalupe Gómez Rodríguez, M.D., Principal investigator, University of Guanjuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245815
- Sponsor's protocol ID
- R-2013-1002-7
- Acronym
- (PEPP)
- Status last verified
- Jan 2021
- First submitted
- 2 Sep 2014
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30898471
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Probiotics (L. Acidophilus Boucardii vs. Multi-species) in the Prevention of Necrotizing Enterocolitis and Their Effect on Secreting IgA in the Feces of Premature Newborns Under Less Than 1500 g
- ClinicalTrials.gov ID
- NCT02245815
- Acronym / sponsor ID
- (PEPP) / R-2013-1002-7
- Conditions
- Infectious Diseases
- Keywords
- Necrotizing enterocolitis, Probiotics, Secreting IgA, Preterm newborns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Posted 28 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| use probiotics boucardii | Experimental | Dietary Supplement: use probiotics boucardiiwas administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks |
| use probiotics Multi-species | Experimental | Dietary Supplement: use probiotics Multi-specieswas administered the probiotic 1x10⁹ colonies forming units per day for 3 weeks |
Who may qualify
- Ages
- 27 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use probiotics boucardiigroup 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 supplement | use probiotics boucardii |
| use probiotics Multi-speciesGroup 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. | Dietary supplement | use probiotics Multi-species |
Primary outcome
Number of Patients With (NEC)
Time frame: 3 weeks
(NEC) was evaluated according to Bell's criteria and only considered in case of stage II-III
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30898471Gomez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guadalupe Gómez Rodríguez, M.D. principal investigator
University of Guanjuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use probiotics boucardii and use probiotics Multi-species in people with Infectious Diseases, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With (NEC) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02245815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.