Evidence map›Paper›PMID 28813414›Full record

Trial reportNature2017

A randomized synbiotic trial to prevent sepsis among infants in rural India.

Pinaki Panigrahi, Sailajanandan Parida, Nimai C Nanda, Radhanath Satpathy, Lingaraj Pradhan, Dinesh S Chandel, Lorena Baccaglini, Arjit Mohapatra, Subhranshu S Mohapatra, Pravas R Misra and 6 more

Erratum issued 2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Nature, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 274 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
274citing papers in PubMed, 11 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03666572 phase2completednot on this mapstarted 2018, after this paper: background citation

Pilot of a Prebiotic and Probiotic Trial in Young Infants With Severe Acute Malnutrition

TypeinterventionalSponsorInternational Centre for Diarrhoeal Disease Research, BangladeshRan2018 to 2020Enrolled87ConditionsSevere Acute MalnutritionArmsBifidobacterium infantis, Bifidobacterium infantis with prebiotic Lacto-N-neotetraose [LNnT], Placebo (Lactose)
NCT04172012 phase3completednot on this mapstarted 2022, after this paper: background citation

Use of Probiotics to Reduce Infections and Death and Prevent Colonization With Extended-spectrum Beta-lactamase Producing Bacteria, Among Newborn Infants in Haydom and Surrounding Area, Tanzania, a Randomized Controlled Clinical Trial

TypeinterventionalSponsorHaydom Lutheran HospitalRan2022 to 2023Enrolled2,000ConditionsNeonatal SepsisArmsLabinic (R) probiotic mixture, Placebo
3 · Its place in the literature

Who cites it

274 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  20. Gut microbes · 2026
    Article

214 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Pinaki PanigrahiDepartment of Epidemiology, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Nebraska, USA.
Sailajanandan ParidaDepartment of Pediatrics, SCB Medical College, Cuttack, Odisha, India.
Nimai C NandaDepartment of Pediatrics, Ispat General Hospital, Rourkela, Odisha, India.
Radhanath SatpathyAsian Institute of Public Health, Bhubaneswar, Odisha, India.
Lingaraj PradhanDepartment of Pediatrics, Capital Hospital, Bhubaneswar, Odisha, India.
Dinesh S ChandelDepartment of Environmental, Agricultural &Occupational Health, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Lorena BaccagliniDepartment of Epidemiology, Center for Global Health and Development, College of Public Health, University of Nebraska Medical Center, Nebraska, USA.
Arjit MohapatraAsian Institute of Public Health, Bhubaneswar, Odisha, India.
Subhranshu S MohapatraAsian Institute of Public Health, Bhubaneswar, Odisha, India.
Pravas R MisraAsian Institute of Public Health, Bhubaneswar, Odisha, India.
Rama ChaudhryDepartment of Microbiology, All India Institute of Medical Sciences, New Delhi, India.
Hegang H ChenDepartment of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Judith A JohnsonEmerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.
J Glenn MorrisEmerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.
Nigel PanethDepartments of Epidemiology, Pediatrics &Human Development, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.
Ira H GewolbDivision of Neonatology, College of Human Medicine, Michigan State University, East Lansing, Michigan, USA.

Funding

Prevention of Infection in Indian NeonatesU01HD040574 · NICHD · UNIVERSITY OF MARYLAND BALTIMORE · PI PANIGRAHI, PINAKI · 2001 to 2006
$3.6M
Prevention of neonatal infection in the Indian community setting using probioticsR01HD053719 · NICHD · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI PANIGRAHI, PINAKI · 2007 to 2011
$2.3M
NICHD NIH HHS R01 HD053719NICHD NIH HHS U01 HD040574
6 · The paper itself

Abstract

Sepsis in early infancy results in one million annual deaths worldwide, most of them in developing countries. No efficient means of prevention is currently available. Here we report on a randomized, double-blind, placebo-controlled trial of an oral synbiotic preparation (Lactobacillus plantarum plus fructooligosaccharide) in rural Indian newborns. We enrolled 4,556 infants that were at least 2,000 g at birth, at least 35 weeks of gestation, and with no signs of sepsis or other morbidity, and monitored them for 60 days. We show a significant reduction in the primary outcome (combination of sepsis and death) in the treatment arm (risk ratio 0.60, 95% confidence interval 0.48-0.74), with few deaths (4 placebo, 6 synbiotic). Significant reductions were also observed for culture-positive and culture-negative sepsis and lower respiratory tract infections. These findings suggest that a large proportion of neonatal sepsis in developing countries could be effectively prevented using a synbiotic containing L. plantarum ATCC-202195.

Indexed as

AdultDouble-Blind MethodFemaleFollow-Up StudiesHumansIndiaInfantInfant, NewbornLactiplantibacillus plantarumOligosaccharidesSepsisSynbioticsYoung AdultfructooligosaccharideOligosaccharides

Identifiers

PMID28813414

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.