Evidence map›Paper›PMID 34914726›Full record

Trial reportPloS one2021

A randomized controlled trial to evaluate the effect of influenza vaccination and probiotic supplementation on immune response and incidence of influenza-like illness in an elderly population in Indonesia.

Sukamto Koesnoe, Nuning Masjkuri, Asri Adisasmita, Samsuridjal Djauzi, Cissy Kartasasmita, Julitasari Sundoro, Mardiati Nadjib, Mondastri Korib, Alisa Nurul Muthia, Virly Nanda Muzellina and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03695432 (Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT03695432 phase4completednot on this map

Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly

TypeinterventionalSponsorIndonesia UniversityRan2014 to 2016Enrolled910ConditionsInfluenza-like IllnessArmsFlubio, Lacidofil, Placebo Vaccine, Placebo probiotic
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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  3. Review
  4. Review
  5. Review
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

15 authors at 4 institutions in 1 country.

Sukamto KoesnoeDivision of Allergy and Immunology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.ORCID 0000-0002-7941-7743
Nuning MasjkuriDepartment of Epidemiology, Faculty of Public Health University of Indonesia Jakarta, Jakarta, Indonesia.
Asri AdisasmitaDepartment of Epidemiology, Faculty of Public Health University of Indonesia Jakarta, Jakarta, Indonesia.
Samsuridjal DjauziDivision of Allergy and Immunology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
Cissy KartasasmitaDepartment of Child Health, Faculty of Medicine, Padjadjaran University, Hasan Sadikin General Hospital, Bandung, Indonesia.
Julitasari SundoroIndonesian Technical Advisory Group on Immunization, Jakarta, Indonesia.
Mardiati NadjibDepartment of Health Policy and Administration, Faculty of Public Health University of Indonesia, Jakarta, Indonesia.
Mondastri KoribDepartment of Epidemiology, Faculty of Public Health University of Indonesia Jakarta, Jakarta, Indonesia.
Alisa Nurul MuthiaIndonesian Society of Internal Medicine, Jakarta, Indonesia.
Virly Nanda MuzellinaDivision of Gastroenterology, Depertment of Internal Medicine, dr. Cipto Mangunkusomo Hospital, Jakarta, Indonesia.
Ummu HabibahIndonesian Society of Internal Medicine, Jakarta, Indonesia.
Saskia Aziza NursyirwanDivision of Gastroenterology, Depertment of Internal Medicine, dr. Cipto Mangunkusomo Hospital, Jakarta, Indonesia.
Kristoforus Hendra DjayaIndonesian Society of Internal Medicine, Jakarta, Indonesia.
Novilia Sjafri BachtiarPT. Bio Farma, Bandung, Indonesia.
Rini Mulia SariPT. Bio Farma, Bandung, Indonesia.
University of Indonesia · IDIndonesian Pediatric Society · IDPT Bio Farma (Indonesia) · IDDr. Hasan Sadikin General Hospital · ID

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo investigate the effect of influenza vaccination with or without probiotic supplementation on the immune response and incidence of influenza-like illness (ILI) in the elderly.

methodsA randomized double-blind, placebo-controlled trial with a modified factorial design was conducted in 554 healthy elderly subjects aged 67 ± 5.6 (ranging from 60-90) years old in the Primary Health Care Center (Puskesmas area) of the Pulo Gadung District East Jakarta. Subjects received either a trivalent influenza vaccine or placebo at the start of the study, and a probiotic supplement (Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011) or a placebo for 6 months. Subjects were randomly assigned into four intervention groups: influenza vaccine and probiotics (n = 141), influenza vaccine and placebo (n = 136), placebo and probiotics (n = 140), and both placebo (n = 137). The primary outcome was ILI incidence within 6 months. The secondary outcomes were seroprotection and seroconversion rates at 1, 4, and 6 months after administering the interventions.

resultsThis study showed that the trivalent influenza vaccine increased seroprotection (RR 3.6 [95%CI 2.92-4.47]; p<0.010) and seroconversion (RR 29.8 [95%CI 11.1-79.5]; p<0.010) rates 1 month after vaccination in elderly people while the probiotic supplement did not alter influenza antibody titers (p = 1.000 and p = 0.210). The relative ILI incidence risk was similar between vaccinated and non-vaccinated groups, as well as in the probiotic group compared to the non-probiotic group.

conclusionThe tested trivalent influenza vaccine significantly induced seroprotection and seroconversion in the vaccinated subjects, while probiotics administration did not influence these parameters. Vaccinated individuals displayed a similarly low ILI incidence as those in the Control Group. However, the observed trend towards a reduction of ILI incidence with probiotics supplementation warrants further assessments in a larger, at-risk population. CLINICAL TRIAL REGISTRY NUMBER: NCT03695432.

Indexed as

Influenza, HumanLacticaseibacillus rhamnosusLactobacillus helveticusAgedAged, 80 and overDouble-Blind MethodFemaleHumansIncidenceIndonesiaInfluenza VaccinesMaleMiddle AgedProbioticsInfluenza Vaccines

Identifiers

PMID34914726
PMCPMC8675694
OpenAlexW4200565365

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.