Evidence map›Paper›PMID 28874323›Full record

Trial reportVaccine2018

The effect of probiotics and zinc supplementation on the immune response to oral rotavirus vaccine: A randomized, factorial design, placebo-controlled study among Indian infants.

Robin P Lazarus, Jacob John, E Shanmugasundaram, Anand K Rajan, S Thiagarajan, Sidhartha Giri, Sudhir Babji, Rajiv Sarkar, P Saravankumar Kaliappan, Srinivasan Venugopal and 12 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 4 pooled it
5.8field-weighted citation impact, top 3% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 4 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 5 institutions in 3 countries.

Robin P LazarusDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Jacob JohnDepartment of Community Health, Christian Medical College, Vellore, India.
E ShanmugasundaramDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Anand K RajanDepartment of Clinical Virology, Christian Medical College, Vellore, India.
S ThiagarajanDepartment of Clinical Virology, Christian Medical College, Vellore, India.
Sidhartha GiriDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Sudhir BabjiDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Rajiv SarkarDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
P Saravankumar KaliappanDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Srinivasan VenugopalDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Ira PraharajDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Uma RamanDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Meghana ParanjpeDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Nicholas C GrasslyDepartment of Infectious Disease Epidemiology, Imperial College London, London, UK.
Edward P K ParkerDepartment of Infectious Disease Epidemiology, Imperial College London, London, UK.
Umesh D ParasharCenters for Disease Control and Prevention, Atlanta, GA, USA.
Jacqueline E TateCenters for Disease Control and Prevention, Atlanta, GA, USA.
Jessica A FlemingPATH, Seattle, WA, USA.
A Duncan SteeleBill and Melinda Gates Foundation, Seattle, WA, USA.
Jayaprakash MuliyilDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
Asha M AbrahamDepartment of Clinical Virology, Christian Medical College, Vellore, India.
Gagandeep KangDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, India. Electronic address: gkang@cmcvellore.ac.in.
Christian Medical College & Hospital · INCenters for Disease Control and Prevention · USImperial College London · GBBill & Melinda Gates Foundation · USProgram for Appropriate Technology in Health · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundStrategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.

methodsInfants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (10

resultsThe study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): -1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: -4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions.

conclusionsZinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation.

trial registrationThe trial was registered in India (CTRI/2012/05/002677).

Indexed as

Administration, OralAntibodies, ViralDouble-Blind MethodFemaleHumansImmunoglobulin AIndiaInfantLacticaseibacillus rhamnosusMalePlacebosProbioticsRotavirus VaccinesTreatment OutcomeVaccines, AttenuatedZincAntibodies, ViralImmunoglobulin APlacebosRIX4414 vaccineRotavirus VaccinesVaccines, AttenuatedZincIndiaLactobacillus GGPoliovirus vaccineRotavirus vaccinesZinc

Identifiers

PMID28874323
PMCPMC12001858
OpenAlexW2751807845

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

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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.