A Phase 2 interventional study of Probiotic supplementation (Lactobacillus plantarum) in Sepsis, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 3 sites in India. Open to participants aged Up to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-15.
Sponsored by NICHD Global Network for Women's and Children's Health · Phase 2, Interventional, and Prevention
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.
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.
1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's enrollment of 284 is above the median of 105 across 893 interventional studies indexed under Sepsis.
Browse Sepsis studies →NICHD Global Network for Women's and Children's Health is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
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.
Dietary Supplement: Probiotic supplementation (Lactobacillus plantarum)
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.
Also known as: Gastroplan
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.
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).
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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NICHD Global Network for Women's and Children's Health