Neonatal SepsisNCT01214473
Probiotics for Prevention Neonatal Infection
A study testing Synbiotics and Maltodextrin in people with Neonatal Sepsis and Sepsis, run by University of Nebraska at 2 sites in India.
Trial summary
Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world. India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Sepsis, Sepsis, Neonatal Infections
- What is being tested?
- Synbiotics and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,556 participants
- Where
- 2 sitesIndia
- Study dates
- Jun 2007to Nov 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 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All newborn infants in the community >24 hours and <72 hours of age
- 2000 g at birth
- Breastfeeding begun by 24 hr of life
- Able to tolerate oral feeds
- Informed consent by parent or guardian
Who cannot join
- Evidence or suspicion of clinical sepsis before the baby is randomized
- Not on breast feeding by 24 hr
- Inability to establish oral feeds (in case of maternal death or ailment)
- Presence of major congenital anomalies
Trial locations and contacts
2 sites in 1 country.
India2 sites
Center for Advanced Research on Alternative Medicine
Bhubaneswar, Odisha, 751009
Ispat General Hospital
Rourkela, Odisha, 769002
About this study
Official title: Prevention of Neonatal Infection in the Indian Community Setting Using Probiotics
Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world. India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Sepsis accounts for 50% of deaths among community born (and 20% of mortality among hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial resistance, which is increasingly restricting the therapeutic options for medical care providers. Friendly bacteria called "Probiotics" have been used in multiple infectious and inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in many fruits and vegetables and also in human breast milk. These sugars reach the colon undigested and serve as food for the friendly bacteria. The current study uses a probiotic preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to prevent neonatal infections. Currently no conclusive data are available on the utility of probiotics in such conditions. If successful, such inexpensive preventive therapy can be made available to general public in resource poor countries. Similar preparations can also be used in the western world to prevent similar infectious conditions of the neonatal period, especially in preterm infants where sepsis continues to be a major cause of hospital stay and death.
Read the detailed description
Our current study is an attempt to put the well known concept of probiotics through rigorous scientific testing before it could be recommended as a prophylactic therapy against neonatal infections. The study will be conducted in India in 8,442 infants who will receive once daily dosing of probiotics for one week. They will be followed for 60 days at home. We have designed the study with enough power to detect a 20% drop in the incidence rate and plan to collect multiple other demographic data from the mothers and infants to help us discern the possible contribution of other confounding risk factors that have been implicated as cofactors in neonatal infection and death.
This will be a randomized controlled clinical trial involving probiotics (Lactobacillus plantarum 10 billion bacteria and 150 mg of fructo-oligosaccharide). We will use our well established three tier monitoring system in the villages. Infants with any adverse event (including sepsis and other infections) will be brought to attached study hospitals for clinical care. Blood and/or CSG culture will be done using Bactec blood culture system and treatment will be provided based on clinical judgment and microbiological analysis of the blood/CSF and/or other findings such as chest X-ray. Data entry will be done on site and transmitted to the principal investigator's institution in the U.S. A data safety monitoring board convened by expert clinicians, neonatologists, and biostatisticians will monitor the study yearly and more frequently if required. Analyzed data will be published in appropriate journals.
- Conditions
- Neonatal Sepsis, Sepsis, Neonatal Infections
- Being tested
- Synbiotics, Maltodextrin
- Keywords
- Clinical sepsis, Pneumonia, Diarrhea, Probiotics, Synbiotics
- Medical subject headings
- Neonatal Sepsis, Sepsis, Pneumonia, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticsDietary supplement
Lactobacillus plantarum with fructo-oligosaccharide
MaltodextrinDietary supplement
Only maltodextrin as placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Once daily oral administration of a probiotic preparation (1 billion cells of Lactobacillus plantarum and 150 mg of fructooligosaccharides) for one week to newborn infants Receives: Dietary Supplement: Synbiotics |
| Placebo | Placebo comparator | Once daily oral administration of maltodextrin for one week to newborn infants Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sepsis and/or death
Incidence of clinical sepsis and/or death
Measured: During the first 60 days of life
Secondary outcomes (3)
Culture proven sepsis
Incidence of culture proven sepsis (Gram-negative vs. Gram-positive)
Measured: During the first 60 days of life
Other infections
Incidence of other infections
Measured: During the first 60 days of life
Weight gain
Weight gained or lost
Measured: During the first 60 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startJun 2007
- Primary completionJun 2012
- Study completionNov 2013
Why it stopped: DSMB stopped the study due to early effectiveness
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Pinaki Panigrahi, MD,PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214473
- Sponsor's protocol ID
- 0332-10 FB
- Other IDs
- 5R01HD053719
- Status last verified
- Aug 2023
- First submitted
- 30 Sep 2010
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Neonatal Infection in the Indian Community Setting Using Probiotics
- ClinicalTrials.gov ID
- NCT01214473
- Acronym / sponsor ID
- 0332-10 FB
- Conditions
- Neonatal Sepsis, Sepsis, Neonatal Infections
- Keywords
- Clinical sepsis, Pneumonia, Diarrhea, Probiotics, Synbiotics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB stopped the study due to early effectiveness
- Enrolment
- 4,556 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Oct 2010 (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.
Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world. India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Sepsis accounts for 50% of deaths among community born (and 20% of mortality among hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial resistance, which is increasingly restricting the therapeutic options for medical care providers. Friendly bacteria called "Probiotics" have been used in multiple infectious and inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in many fruits and vegetables and also in human breast milk. These sugars reach the colon undigested and serve as food for the friendly bacteria. The current study uses a probiotic preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to prevent neonatal infections. Currently no conclusive data are available on the utility of probiotics in such conditions. If successful, such inexpensive preventive therapy can be made available to general public in resource poor countries. Similar preparations can also be used in the western world to prevent similar infectious conditions of the neonatal period, especially in preterm infants where sepsis continues to be a major cause of hospital stay and death.
Detailed description
Our current study is an attempt to put the well known concept of probiotics through rigorous scientific testing before it could be recommended as a prophylactic therapy against neonatal infections. The study will be conducted in India in 8,442 infants who will receive once daily dosing of probiotics for one week. They will be followed for 60 days at home. We have designed the study with enough power to detect a 20% drop in the incidence rate and plan to collect multiple other demographic data from the mothers and infants to help us discern the possible contribution of other confounding risk factors that have been implicated as cofactors in neonatal infection and death.
This will be a randomized controlled clinical trial involving probiotics (Lactobacillus plantarum 10 billion bacteria and 150 mg of fructo-oligosaccharide). We will use our well established three tier monitoring system in the villages. Infants with any adverse event (including sepsis and other infections) will be brought to attached study hospitals for clinical care. Blood and/or CSG culture will be done using Bactec blood culture system and treatment will be provided based on clinical judgment and microbiological analysis of the blood/CSF and/or other findings such as chest X-ray. Data entry will be done on site and transmitted to the principal investigator's institution in the U.S. A data safety monitoring board convened by expert clinicians, neonatologists, and biostatisticians will monitor the study yearly and more frequently if required. Analyzed data will be published in appropriate journals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: SynbioticsOnce daily oral administration of a probiotic preparation (1 billion cells of Lactobacillus plantarum and 150 mg of fructooligosaccharides) for one week to newborn infants |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinOnce daily oral administration of maltodextrin for one week to newborn infants |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- All newborn infants in the community >24 hours and <72 hours of age
- 2000 g at birth
- Breastfeeding begun by 24 hr of life
- Able to tolerate oral feeds
- Informed consent by parent or guardian
Key exclusion criteria (4 listed)
- Evidence or suspicion of clinical sepsis before the baby is randomized
- Not on breast feeding by 24 hr
- Inability to establish oral feeds (in case of maternal death or ailment)
- Presence of major congenital anomalies
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 |
|---|---|---|
| SynbioticsLactobacillus plantarum with fructo-oligosaccharide | Dietary supplement | Probiotic group |
| MaltodextrinOnly maltodextrin as placebo | Dietary supplement | Placebo |
Primary outcome
Clinical sepsis and/or death
Time frame: During the first 60 days of life
Incidence of clinical sepsis and/or death
3 secondary outcomes
Culture proven sepsis
Time frame: During the first 60 days of life
Other infections
Time frame: During the first 60 days of life
Weight gain
Time frame: During the first 60 days of life
Results and safety
The study was stopped early (reason given: DSMB stopped the study due to early effectiveness). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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.
Pinaki Panigrahi, MD,PhD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotics and Maltodextrin in people with Neonatal Sepsis and Sepsis, run by University of Nebraska at 2 sites in India.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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. 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 was stopped early (reason given: DSMB stopped the study due to early effectiveness). Results are not available in the source record.
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?
Clinical sepsis and/or death (time frame: During the first 60 days of life). 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 23 Aug 2023.