Infectious DiseasesPhase 2EPPNCT02226263
Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics
A Phase 2 study testing probiotics Lactobacillus acidophilus boucardii 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 know the effects of probiotics on the incidence of Necrotizing Enterocolitis (NEC) in preterm infants 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?
- probiotics Lactobacillus acidophilus boucardii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2010to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- We studied 150 preterm newborns <1500gr who were recruited on the day that began enteral feeding according to the decision of the treating physician.
Who cannot join
- Preterm infants > 1500g with Apgar score <6 at 5 minutes, gastrointestinal malformations, fetopathies, patent ductus arteriosis with hemodynamic decompensation, asphyxia, and NEC suspected as classified by Bell were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics Lactobacillus Boucardii.
The purpose of this study is to know the effects of probiotics on the incidence of Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.
Read the detailed description
The investigators performed a clinical, randomized, double-blind trial in preterm infants <1500g from March 1, 2010 to February 28, 2012. Group A received enteral stimulation trophic five days and later increments 20ml/k/day of breast milk or formula for premature; the group B apart from the above the probiotic Lactobacillus acidophilus (boucardii strain) 1 X109 colonic forming unit (CFU)/ day for 4 weeks was added. Gastric tolerance, evolution, reason for discharge, and the development of Necrotizing enterocolitis was monitored. The diagnosis of Necrotizing enterocolitis was made by the treating physician according to Bell's criteria and was blinded to group assignments.The formulas were prepared by one of the investigators according to the group each patient was assigned. Using sterile technique, the probiotic with 1x109 (CFU) Lactobacillus acidophilus (boucardii strain) was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants. In case of control group only breast milk or formula for preterm infants was used.
All formulas were labeled for each patient and were delivered to the nurse in charge of infant feeding at 9:00 and 21:00 h.
Characteristics of Sample size and statistical analysis:
Sample size showed that the investigators needed 190 total preterm infants, based on the expected 50% decrease in the incidence of severe necrotizing enterocolitis in preterm neonates who received probiotics compared with control group with α 0.05 and β 0.20. Student´s t test or Mann Whitney U test were performed for mean differences regarding the general characteristics in the two study groups, Chi square or Fisher´s test for differences in proportions for mortality and complications between groups.
- Conditions
- Infectious Diseases
- Being tested
- probiotics Lactobacillus acidophilus boucardii
- Keywords
- Necrotizing enterocolitis, Probiotics, 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.
probiotics Lactobacillus acidophilus boucardiiDietary supplement
Also called Gastric tolerance, characteristics of discharges, evolution, reason for discharge, and the development of NEC was monitored.
Using sterile technique, the probiotic with 1x109 [CFU] Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants.
| Study group | Role | What they receive |
|---|---|---|
| probiotics Lactobacillus acidophilus boucardii strain. | Experimental | Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks .The probiotic presentation used was powder in an envelope with 160mg (Carnot ® Laboratories), scientific products, Mexico, (Registration Number 274M91SSA). This was stored in a dry place at room temperature, avoiding sunlight. Receives: Dietary Supplement: probiotics Lactobacillus acidophilus boucardii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe necrotizing enterocolitis in preterm newborns <1500g
Group A received enteral stimulation trophic five days and later increments 20ml/k/day of breast milk or formula for premature; the group B apart from the above the probiotic Lactobacillus boucardii 1 X109 (CFU) / day for 4 weeks was added.
Measured: 23 month
Secondary outcomes (1)
Adverse effects with probiotic use in preterm newborns <1500g.
The amount of food was increased slowly if tolerated according to the Clinical Practice Guidelines for enteral feeding preterm in our hospital, enteral feeding was interrupted if there was any sign of intolerance such as vomiting, presence of bile or blood content by probe orogastric, bloating, or bloody stools which were assessed and recorded daily.Our primary outcome was the presence of severe necrotizing enterocolitis (NEC) monitored by the Bell´s criteria; secondarily we evaluated the presence of sepsis diagnosed with clinical signs of systemic inflammatory response and positive blood culture.
Measured: 23 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 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, M.D., Principal investigator, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226263
- Sponsor's protocol ID
- R-2010-1002-12
- Acronym
- EPP
- Status last verified
- Aug 2014
- First submitted
- 22 Jul 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics Lactobacillus Boucardii.
- ClinicalTrials.gov ID
- NCT02226263
- Acronym / sponsor ID
- EPP / R-2010-1002-12
- Conditions
- Infectious Diseases
- Keywords
- Necrotizing enterocolitis, Probiotics, Preterm newborns
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
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 know the effects of probiotics on the incidence of Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.
Detailed description
The investigators performed a clinical, randomized, double-blind trial in preterm infants <1500g from March 1, 2010 to February 28, 2012. Group A received enteral stimulation trophic five days and later increments 20ml/k/day of breast milk or formula for premature; the group B apart from the above the probiotic Lactobacillus acidophilus (boucardii strain) 1 X109 colonic forming unit (CFU)/ day for 4 weeks was added. Gastric tolerance, evolution, reason for discharge, and the development of Necrotizing enterocolitis was monitored. The diagnosis of Necrotizing enterocolitis was made by the treating physician according to Bell's criteria and was blinded to group assignments.The formulas were prepared by one of the investigators according to the group each patient was assigned. Using sterile technique, the probiotic with 1x109 (CFU) Lactobacillus acidophilus (boucardii strain) was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants. In case of control group only breast milk or formula for preterm infants was used.
All formulas were labeled for each patient and were delivered to the nurse in charge of infant feeding at 9:00 and 21:00 h.
Characteristics of Sample size and statistical analysis:
Sample size showed that the investigators needed 190 total preterm infants, based on the expected 50% decrease in the incidence of severe necrotizing enterocolitis in preterm neonates who received probiotics compared with control group with α 0.05 and β 0.20. Student´s t test or Mann Whitney U test were performed for mean differences regarding the general characteristics in the two study groups, Chi square or Fisher´s test for differences in proportions for mortality and complications between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| probiotics Lactobacillus acidophilus boucardii strain. | Experimental | Dietary Supplement: probiotics Lactobacillus acidophilus boucardiiLactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks .The probiotic presentation used was powder in an envelope with 160mg (Carnot ® Laboratories), scientific products, Mexico, (Registration Number 274M91SSA). This was stored in a dry place at room temperature, avoiding sunlight. |
Who may qualify
- Ages
- 27 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- We studied 150 preterm newborns <1500gr who were recruited on the day that began enteral feeding according to the decision of the treating physician.
Key exclusion criteria (1 listed)
- Preterm infants > 1500g with Apgar score <6 at 5 minutes, gastrointestinal malformations, fetopathies, patent ductus arteriosis with hemodynamic decompensation, asphyxia, and NEC suspected as classified by Bell were excluded from the study.
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 |
|---|---|---|
| probiotics Lactobacillus acidophilus boucardiiAlso: Gastric tolerance, characteristics of discharges, evolution, reason for discharge, and the development of NEC was monitored.Using sterile technique, the probiotic with 1x109 [CFU] Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants. | Dietary supplement | probiotics Lactobacillus acidophilus boucardii strain. |
Primary outcome
Incidence of severe necrotizing enterocolitis in preterm newborns <1500g
Time frame: 23 month
Group A received enteral stimulation trophic five days and later increments 20ml/k/day of breast milk or formula for premature; the group B apart from the above the probiotic Lactobacillus boucardii 1 X109 (CFU) / day for 4 weeks was added.
1 secondary outcome
Adverse effects with probiotic use in preterm newborns <1500g.
Time frame: 23 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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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, M.D. principal investigator
Universidad de Guanajuato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing probiotics Lactobacillus acidophilus boucardii 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 27 Aug 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of severe necrotizing enterocolitis in preterm newborns <1500g (time frame: 23 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2014.