SepsisPhase 2NCT00518596
Prevention of Infection in Indian Neonates - Phase II Probiotics Study
A Phase 2 study testing Probiotic supplementation (Lactobacillus plantarum) in people with Sepsis, run by NICHD Global Network for Women's and Children's Health at 3 sites in India.
Trial summary
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Probiotic supplementation (Lactobacillus plantarum)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 3 sitesIndia
- Study dates
- Jul 2005to Aug 2006
- 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 Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants ≥ 35 weeks and ≥1800g born in the hospital
- Infants > 12 hours and < 72 hours of age at enrollment
- Infants likely to be hospitalized for 5-7 days without antibiotic treatment
- Informed consent by one parent or guardian
- Infants begun breastfeeding
Who cannot join
- Antibiotic therapy prior to enrollment
- Evidence or suspicion of clinical sepsis before randomization
- Inability (as determined by the physician) to tolerate oral feeding of study supplement
- Presence of major congenital anomalies
- Infant's home is >30km away from hospital A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Capital Hospital
Bhubaneswar, Odisha
Kalinga Hospital
Bhubaneswar, Odisha
Ispat General Hospital
Rourkela, Odisha
About this study
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.
Read the detailed description
Phase II is a hospital based intervention (n = 297 infants) measuring the colonizing ability, safety, and tolerance of a probiotic supplement, Lactobacillus plantarum in the neonatal gut. Newborn infants ≥ 35 weeks of gestation will be randomized to receive either L. plantarum preparations (containing 109 organisms) or placebo preparations orally once a day for the first 7 days of life. The final stage of the project will be a community-based randomized double-blind placebo-controlled trial of L. plantarum enrolling over 8,000 newborns to examine the efficacy of probiotic supplementation in reducing neonatal infection in Indian neonates.
- Conditions
- Sepsis
- Being tested
- Probiotic supplementation (Lactobacillus plantarum)
- Keywords
- Neonatal, Sepsis, Global Network, Probiotics, India, International, Maternal and child health
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementation (Lactobacillus plantarum)Dietary supplement
Also called Gastroplan
GastroPlan capsules from a single lot will be used. The intervention consists of L. plantarum reconstituted in sterile 2.0 cc of 5% dextrose-saline, administered orally using an opaque-amber syringe.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Arm | Experimental | Newborn infants' ≥ 35 weeks of gestation and ≥1800g, given L. plantarum preparations orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter. Receives: Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum) |
| Control Arm | Placebo comparator | Newborn infants' ≥ 35 weeks of gestation and ≥1800g, receiving placebo preparations (a control solution of sterile 2.0 cc 5% dextrose-saline)orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter. Receives: Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
Measured: 28 days
Clinical safety (including sepsis and death) and tolerance of a daily administration of oral L. plantarum probiotic supplement when used in healthy full-term neonates.
Measured: 28 days
Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.
Secondary outcomes (1)
Feasibility of the future community study (consent and retention rates, completeness of stool sampling, ability to complete the study in the home for infants discharged early).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startJul 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, All India Institute of Medical Sciences, TN Medical College, Mumbai, Department of Health and Family Welfare, Orissa, SCB Medical College, Cuttack, Capital Hospital, Bhubaneswar, Ispat General Hospital, Rourkela, Kalinga Hospital, Bhubaneswar, University of Maryland
- Responsible party
- Sponsor
- Investigators
- Pinaki Panigrahi, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518596
- Sponsor's protocol ID
- GN 07 Phase II
- Other IDs
- U01HD040574, R01HD053719
- Status last verified
- Jun 2017
- First submitted
- 20 Aug 2007
- Last updated
- 15 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Infection in Indian Neonates - Phase II Probiotics Study
- ClinicalTrials.gov ID
- NCT00518596
- Acronym / sponsor ID
- GN 07 Phase II
- Conditions
- Sepsis
- Keywords
- Neonatal, Sepsis, Global Network, Probiotics, India, International, Maternal and child health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, All India Institute of Medical Sciences, TN Medical College, Mumbai, Department of Health and Family Welfare, Orissa, SCB Medical College, Cuttack, Capital Hospital, Bhubaneswar, Ispat General Hospital, Rourkela, Kalinga Hospital, Bhubaneswar, University of Maryland
- Study start
- Jul 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 21 Aug 2007 (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.
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.
Detailed description
Phase II is a hospital based intervention (n = 297 infants) measuring the colonizing ability, safety, and tolerance of a probiotic supplement, Lactobacillus plantarum in the neonatal gut. Newborn infants ≥ 35 weeks of gestation will be randomized to receive either L. plantarum preparations (containing 109 organisms) or placebo preparations orally once a day for the first 7 days of life. The final stage of the project will be a community-based randomized double-blind placebo-controlled trial of L. plantarum enrolling over 8,000 newborns to examine the efficacy of probiotic supplementation in reducing neonatal infection in Indian neonates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Arm | Experimental | Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)Newborn infants' ≥ 35 weeks of gestation and ≥1800g, given L. plantarum preparations orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter. |
| Control Arm | Placebo comparator | Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)Newborn infants' ≥ 35 weeks of gestation and ≥1800g, receiving placebo preparations (a control solution of sterile 2.0 cc 5% dextrose-saline)orally once a day starting on day 1, 2, or 3 of life and continuing for seven days thereafter. |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants ≥ 35 weeks and ≥1800g born in the hospital
- Infants > 12 hours and < 72 hours of age at enrollment
- Infants likely to be hospitalized for 5-7 days without antibiotic treatment
- Informed consent by one parent or guardian
- Infants begun breastfeeding
Key exclusion criteria (5 listed)
- Antibiotic therapy prior to enrollment
- Evidence or suspicion of clinical sepsis before randomization
- Inability (as determined by the physician) to tolerate oral feeding of study supplement
- Presence of major congenital anomalies
- Infant's home is >30km away from hospital A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
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 |
|---|---|---|
| Probiotic supplementation (Lactobacillus plantarum)Also: GastroplanGastroPlan capsules from a single lot will be used. The intervention consists of L. plantarum reconstituted in sterile 2.0 cc of 5% dextrose-saline, administered orally using an opaque-amber syringe. | Dietary supplement | Control Arm, Probiotic Arm |
Primary outcome
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
Time frame: 28 days
Clinical safety (including sepsis and death) and tolerance of a daily administration of oral L. plantarum probiotic supplement when used in healthy full-term neonates.
Time frame: 28 days
Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.
1 secondary outcome
Feasibility of the future community study (consent and retention rates, completeness of stool sampling, ability to complete the study in the home for infants discharged early).
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 15 Jun 2017.
- Global Network for Women's and Children's Health ResearchLink provided by the sponsor.
- RTI InternationalLink provided by the sponsor.
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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, M.D. principal investigator
University of Maryland, Baltimore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic supplementation (Lactobacillus plantarum) in people with Sepsis, run by NICHD Global Network for Women's and Children's Health at 3 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 5 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration. (time frame: 28 days). 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 15 Jun 2017.