Late Onset Neonatal SepsisNCT02073214
Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates.
A study testing Probiotic in people with Late Onset Neonatal Sepsis and Necrotizing Enterocolitis, run by IBSS Biomed S.A..
Trial summary
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis, Infant, Very Low Birth Weight
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 2013
- Phase
- Interventional
- 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 Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants ≥ 750 g and ≤ 1800 g at birth
- Gestational age of ≤ 34 weeks
- Mother's age ≥ 18 years
- Possibility of feeding by enteral route
- Possibility of enrolment ≤ 48 hours of age
- Caucasian race
- Parent-legal guardian informed consent obtained in writing
Who cannot join
- Infants < 750 g and > 1800 g at birth
- Gestational age of > 34 weeks
- Mother's age < 18 years
- Contraindicated to enteral nutrition within the first 48 hours of life
- Birth asphyxia (Apgar score: 0-3)
- Major congenital abnormalities, including gastrointestinal abnormalities
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- Severe clinical condition / disorders which the Investigator considers a contraindication to study participation, including the presence of at least 3 out of 4 of the following symptoms:
- necessity of mechanical ventilation and FiO2 more than 0.6 elevation to maintain blood oxygen saturation within 88-93%,
- metabolic acidosis, pH less than 7.20 and BE more than (-10),
- necessity of vasopressor (antihypotensive) agents to maintain proper arterial blood pressure,
- signs of damage to at least one vital organ (liver, kidneys, gastrointestinal tract, adrenal glands).
- Administration of other probiotic preparations
- Enrolment in any other clinical trial throughout the study period
- Lack of parent-legal guardian informed consent
About this study
Official title: Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates. Multi-centre, Randomised, Double-blind, Placebo-controlled Clinical Study.
The purpose of this study was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates. The study was also intended to investigate reduction of colonisation by pathogenic bacteria and to estimate the incidence of gastrointestinal disorders.
Probotic bacteria contained in the investigational product administered directly after birth are beneficial for the development of normal gut microflora and can prevent or significantly limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic flora in a hospital setting. Permanent colonisation with commensal flora in very early life improves gastrointestinal function in premature neonates by reducing the onset of or by decreasing the severity of the signs and symptoms of feeding intolerance and generalised bacterial infections, including sepsis and necrotizing enterocolitis.
Read the detailed description
Neonates defined as having very low birth weight (VLBW) are found to have a number of conditions typical for this period of life and body weight at birth. Perinatal and neonatal infections are relatively common in these babies, which can be attributed to their immunological immaturity (immature cellular or humoral immune responsiveness) and insufficient gastrointestinal tract colonisation by non-pathogenic bacteria, the presence of which depends on the type of delivery, feeding and environment in which the neonates are nursed.
Neonates admitted to neonatal intensive care units, particularly low birth-weight neonates born prematurely or with congenital disorders, are most susceptible. Probiotics administered to neonates are known to compete with pathogenic bacteria for essential nutrients and receptor sites, and to enzymatically modify toxin receptors. They are also known to produce antimicrobial substances, acidify the intestinal environment and stimulate the immune system, helping it reach full maturity. These are the reasons why intestinal microflora normalisation with the help of probiotics can be beneficial for VLBW neonates, especially those requiring intensive medical care.
In a review of clinical studies on the use of probiotics in NEC prevention in neonates, demonstrated beneficial effects of probiotics in a group of VLBW neonates compared to placebo. There are scientific reasons to believe that probiotics administered to neonates modulate the composition of the gut flora colonising the intestinal tract and are beneficial for the development and maturity of the immune system. In hitherto clinical studies, specific probiotic strains were found to provide beneficial effects by limiting infections in the neonatal period, including necrotizing enterocolitis in VLBW neonates.
The purpose of this multicentre, randomized study was to investigate whether the use of a probiotic preparation containing Lactobacillus rhamnosus KL53A and Bifidobacterium breve PB04 influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates and reduction of colonisation by pathogenic bacteria and to estimate the incidence of gastrointestinal disorders. The study took place between April 2012 and July 2013 in eight study centres in Poland. It was conducted in accordance with the original protocol and according to ICH-GCP requirements.
The duration of subject's participation in the trial was approximately 49 days, or until they were withdrawn or discharged from the hospital, whichever came earlier, prior to day 49.
As the trial did not concern medicinal product but the foodstuff (food for special medical purpose) it did not require Authority approval but was only subject to relevant Ethics Committee approval.
The study only included neonates who fulfilled the eligibility criteria, after obtaining an informed consent from their parents/legal guardians, to have their baby enrolled in the study and randomized into one of the two study groups: probiotic or placebo. Investigational product were administered during the first 48h of life, at the time of the enteral feed.
Efficacy evaluation was to determine whether the investigational product positively influences the emergence and progressive development of the natural gut flora and the clinical status of preterm VLBW neonates. As part of the efficacy evaluation, it was also examined whether the probiotic agent has the capacity to inhibit pathogenic colonisation and to reduce the incidence of gastrointestinal disorders, as compared to placebo.
Safety was evaluated by determining whether investigational product in VLBW preterm neonates increases AE/SAE incidence and influences the type of adverse events and serious adverse events as compared to placebo.
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Neonatal Sepsis, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
Also called Food for special medical purposes
Standard treatment plus probiotic
PlaceboOther
Standard treatment plus placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Single dose of probiotic, was administered enterally twice daily with food (in the morning and in the evening). The first dose of probiotic was administered within the first 48 hours after birth. The probiotic administration was continued for 6 weeks or until hospital discharge (whichever was earlier).
Discontinuation of the enteral nutrition was equivalent with discontinuation of the administration of the probiotic. If the probiotic was discontinued for more than 7 days, the patient was withdrawn from the study. Receives: Other: Probiotic |
| Placebo | Placebo comparator | Single dose of placebo was administered enterally twice daily with food (in the morning and in the evening). The first dose of placebo was administered within the first 48 hours after birth. The placebo administration was continued for 6 weeks or until hospital discharge (whichever was earlier).
Discontinuation of the enteral nutrition was equivalent with discontinuation of the administration of the placebo. If the placebo was discontinued for more than 7 days, the patient was withdrawn from the study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tract colonisation
Bacteriological tests involved quantitative and qualitative assessment of neonatal gut flora during clinical follow-up. Bacterial populations of Lactobacillus and Bifidobacterium as well as pathogenic bacteria were assesed.
Stool samples were collected at 7-day intervals (±2 days) in the period of investigational product intake, and on Day 7 (±2 days) after the last dose of the investigational product.
Measured: Assesed on days 1, 7, 14, 21, 28, 35, 42 and 49 (assesed weekly within eight weeks)
Feeding intolerance episodes (including: gastric residuals, vomiting, regurgitation of food, abdominal distension, abdominal rigidity, gut motility disorders)
Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Incidence and type of adverse events and serious adverse events with special regard to sepsis caused by bacteria contained in investigational product.
Safety was evaluated by determining whether investigational product in VLBW preterm neonates increases AE/SAE incidence and influences the type of adverse events and serious adverse events as compared to placebo with special regard to sepsis caused by bacteria contained in investigational product .
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Secondary outcomes (9)
Late onset sepsis caused by Gram positive or Gram negative bacteria
Sepsis was confirmed by positive blood cultures. Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Gastrointestinal perforation
Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Duration of total parenteral nutrition (days)
Duration of total parenteral nutrition (hyperalimentation) was evaluated until full enteral nutrition is restored.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Duration (days) of absence of enteral nutrition due to gastrointestinal disorders
Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Duration (days) of absence of enteral nutrition for reasons other than gastrointestinal disorders
Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Weight, length and head circumference
Weight, length and head circumference were evaluated throughout the period of care according to standard neonatal care procedures.
Measured: Weight was measured once daily, head circumference was measured once a week, and body length was measured on Day 1 and on Day 7 (±2 days) from the last dose (or until the patient was discharged or withdrawn from the study)
NEC - intensity and severity
Severity of neonatal necrotizing enterocolitis was determined according Bell's criteria. Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Mortality rate, with a focus on deaths attributed to NEC and sepsis
Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Duration of hospitalization (days) (until discharge)
Duration of hospitalization was investigated from the date of patient enrolment until discharge.
Measured: Assesed on a daily basis (from 1 to 42 and on day 49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Onset Neonatal SepsisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSS Biomed S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Science and Higher Education, Poland
- Responsible party
- Sponsor
- Investigators
- Ryszard Lauterbach, Prof., MD, Principal investigator, Jagiellonian University Medical College, Department of Neonatology, Kopernika 23 St., 31-501 Krakow, PolandAleksandra M Cichonska, PhD, Study director, IBSS Biomed S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073214
- Sponsor's protocol ID
- PB-DM/SBK-NEC-01/11
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Probiotic Supplementation on the Clinical Status of Very-low-birth-weight Preterm Neonates. Multi-centre, Randomised, Double-blind, Placebo-controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT02073214
- Acronym / sponsor ID
- PB-DM/SBK-NEC-01/11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- IBSS Biomed S.A.Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Science and Higher Education, Poland
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Feb 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 was to evaluate the safety of a probiotic foodstuff and its influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates. The study was also intended to investigate reduction of colonisation by pathogenic bacteria and to estimate the incidence of gastrointestinal disorders.
Probotic bacteria contained in the investigational product administered directly after birth are beneficial for the development of normal gut microflora and can prevent or significantly limit gastrointestinal colonisation by pathogenic bacteria and the development of pathogenic flora in a hospital setting. Permanent colonisation with commensal flora in very early life improves gastrointestinal function in premature neonates by reducing the onset of or by decreasing the severity of the signs and symptoms of feeding intolerance and generalised bacterial infections, including sepsis and necrotizing enterocolitis.
Detailed description
Neonates defined as having very low birth weight (VLBW) are found to have a number of conditions typical for this period of life and body weight at birth. Perinatal and neonatal infections are relatively common in these babies, which can be attributed to their immunological immaturity (immature cellular or humoral immune responsiveness) and insufficient gastrointestinal tract colonisation by non-pathogenic bacteria, the presence of which depends on the type of delivery, feeding and environment in which the neonates are nursed.
Neonates admitted to neonatal intensive care units, particularly low birth-weight neonates born prematurely or with congenital disorders, are most susceptible. Probiotics administered to neonates are known to compete with pathogenic bacteria for essential nutrients and receptor sites, and to enzymatically modify toxin receptors. They are also known to produce antimicrobial substances, acidify the intestinal environment and stimulate the immune system, helping it reach full maturity. These are the reasons why intestinal microflora normalisation with the help of probiotics can be beneficial for VLBW neonates, especially those requiring intensive medical care.
In a review of clinical studies on the use of probiotics in NEC prevention in neonates, demonstrated beneficial effects of probiotics in a group of VLBW neonates compared to placebo. There are scientific reasons to believe that probiotics administered to neonates modulate the composition of the gut flora colonising the intestinal tract and are beneficial for the development and maturity of the immune system. In hitherto clinical studies, specific probiotic strains were found to provide beneficial effects by limiting infections in the neonatal period, including necrotizing enterocolitis in VLBW neonates.
The purpose of this multicentre, randomized study was to investigate whether the use of a probiotic preparation containing Lactobacillus rhamnosus KL53A and Bifidobacterium breve PB04 influence on emergence and development of natural intestinal flora and the clinical status of premature very low birth weight neonates and reduction of colonisation by pathogenic bacteria and to estimate the incidence of gastrointestinal disorders. The study took place between April 2012 and July 2013 in eight study centres in Poland. It was conducted in accordance with the original protocol and according to ICH-GCP requirements.
The duration of subject's participation in the trial was approximately 49 days, or until they were withdrawn or discharged from the hospital, whichever came earlier, prior to day 49.
As the trial did not concern medicinal product but the foodstuff (food for special medical purpose) it did not require Authority approval but was only subject to relevant Ethics Committee approval.
The study only included neonates who fulfilled the eligibility criteria, after obtaining an informed consent from their parents/legal guardians, to have their baby enrolled in the study and randomized into one of the two study groups: probiotic or placebo. Investigational product were administered during the first 48h of life, at the time of the enteral feed.
Efficacy evaluation was to determine whether the investigational product positively influences the emergence and progressive development of the natural gut flora and the clinical status of preterm VLBW neonates. As part of the efficacy evaluation, it was also examined whether the probiotic agent has the capacity to inhibit pathogenic colonisation and to reduce the incidence of gastrointestinal disorders, as compared to placebo.
Safety was evaluated by determining whether investigational product in VLBW preterm neonates increases AE/SAE incidence and influences the type of adverse events and serious adverse events as compared to placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: ProbioticSingle dose of probiotic, was administered enterally twice daily with food (in the morning and in the evening). The first dose of probiotic was administered within the first 48 hours after birth. The probiotic administration was continued for 6 weeks or until hospital discharge (whichever was earlier). Discontinuation of the enteral nutrition was equivalent with discontinuation of the administration of the probiotic. If the probiotic was discontinued for more than 7 days, the patient was withdrawn from the study. |
| Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo was administered enterally twice daily with food (in the morning and in the evening). The first dose of placebo was administered within the first 48 hours after birth. The placebo administration was continued for 6 weeks or until hospital discharge (whichever was earlier). Discontinuation of the enteral nutrition was equivalent with discontinuation of the administration of the placebo. If the placebo was discontinued for more than 7 days, the patient was withdrawn from the study. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants ≥ 750 g and ≤ 1800 g at birth
- Gestational age of ≤ 34 weeks
- Mother's age ≥ 18 years
- Possibility of feeding by enteral route
- Possibility of enrolment ≤ 48 hours of age
Key exclusion criteria (14 listed)
- Infants < 750 g and > 1800 g at birth
- Gestational age of > 34 weeks
- Mother's age < 18 years
- Contraindicated to enteral nutrition within the first 48 hours of life
- Birth asphyxia (Apgar score: 0-3)
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 |
|---|---|---|
| ProbioticAlso: Food for special medical purposesStandard treatment plus probiotic | Other | Probiotic |
| PlaceboStandard treatment plus placebo | Other | Placebo |
Primary outcome
Gastrointestinal tract colonisation
Time frame: Assesed on days 1, 7, 14, 21, 28, 35, 42 and 49 (assesed weekly within eight weeks)
Bacteriological tests involved quantitative and qualitative assessment of neonatal gut flora during clinical follow-up. Bacterial populations of Lactobacillus and Bifidobacterium as well as pathogenic bacteria were assesed. Stool samples were collected at 7-day intervals (±2 days) in the period of investigational product intake, and on Day 7 (±2 days) after the last dose of the investigational product.
Feeding intolerance episodes (including: gastric residuals, vomiting, regurgitation of food, abdominal distension, abdominal rigidity, gut motility disorders)
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Clinical parameters were evaluated throughout the period of care according to standard neonatal care procedures.
Incidence and type of adverse events and serious adverse events with special regard to sepsis caused by bacteria contained in investigational product.
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Safety was evaluated by determining whether investigational product in VLBW preterm neonates increases AE/SAE incidence and influences the type of adverse events and serious adverse events as compared to placebo with special regard to sepsis caused by bacteria contained in investigational product .
9 secondary outcomes
Late onset sepsis caused by Gram positive or Gram negative bacteria
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Gastrointestinal perforation
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Duration of total parenteral nutrition (days)
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Duration (days) of absence of enteral nutrition due to gastrointestinal disorders
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Duration (days) of absence of enteral nutrition for reasons other than gastrointestinal disorders
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Weight, length and head circumference
Time frame: Weight was measured once daily, head circumference was measured once a week, and body length was measured on Day 1 and on Day 7 (±2 days) from the last dose (or until the patient was discharged or withdrawn from the study)
NEC - intensity and severity
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Mortality rate, with a focus on deaths attributed to NEC and sepsis
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
Duration of hospitalization (days) (until discharge)
Time frame: Assesed on a daily basis (from 1 to 42 and on day 49)
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 Feb 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.
Ryszard Lauterbach, Prof., MD principal investigator
Jagiellonian University Medical College, Department of Neonatology, Kopernika 23 St., 31-501 Krakow, Poland
Aleksandra M Cichonska, PhD study director
IBSS Biomed S.A.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Late Onset Neonatal Sepsis and Necrotizing Enterocolitis, run by IBSS Biomed S.A..
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 7 inclusion and 14 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Gastrointestinal tract colonisation (time frame: Assesed on days 1, 7, 14, 21, 28, 35, 42 and 49 (assesed weekly within eight weeks)). The study lists 3 primary outcomes in all. 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 Feb 2014.