Probiotics for Prevention Neonatal Infection
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ClinicalTrials.gov Identifier: NCT01214473 |
Recruitment Status
:
Terminated
(DSMB stopped the study due to early effectiveness)
First Posted
: October 5, 2010
Last Update Posted
: August 26, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neonatal Sepsis Sepsis Neonatal Infections | Other: Synbiotics Other: Maltodextrin | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4556 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Prevention of Neonatal Infection in the Indian Community Setting Using Probiotics |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Probiotic group
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
|
Other: Synbiotics
Lactobacillus plantarum with fructo-oligosaccharide
|
Placebo Comparator: Placebo
Once daily oral administration of maltodextrin for one week to newborn infants
|
Other: Maltodextrin
Only maltodextrin as placebo
|
- Clinical sepsis and/or death [ Time Frame: During the first 60 days of life ]
- Incidence of culture proven sepsis (Gram-negative vs. Gram-positive) [ Time Frame: During the first 60 days of life ]
- Incidence of other infections [ Time Frame: During the first 60 days of life ]
- Effect on weight gain [ Time Frame: During the first 60 days of life ]

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Ages Eligible for Study: | up to 3 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214473
India | |
Center for Advanced Research on Alternative Medicine | |
Bhubaneswar, Orissa, India, 751009 | |
Ispat General Hospital | |
Rourkela, Orissa, India, 769002 |
Principal Investigator: | Pinaki Panigrahi, MD,PhD | University of Nebraska |
Responsible Party: | Pinaki Panigrahi, Principal Investigator, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT01214473 History of Changes |
Other Study ID Numbers: |
332-10 FB 5R01HD053719 ( U.S. NIH Grant/Contract ) |
First Posted: | October 5, 2010 Key Record Dates |
Last Update Posted: | August 26, 2014 |
Last Verified: | August 2014 |
Keywords provided by Pinaki Panigrahi, University of Nebraska:
Clinical sepsis Pneumonia Diarrhea Probiotics Synbiotics |
Additional relevant MeSH terms:
Infection Communicable Diseases Sepsis Toxemia Neonatal Sepsis |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Infant, Newborn, Diseases |