Evidence map›Paper›PMID 33926519›Full record

ArticleTrials2021

Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial.

Kanika Kuwelker, Nina Langeland, Iren Høyland Löhr, Joshua Gidion, Joel Manyahi, Sabrina John Moyo, Bjørn Blomberg, Claus Klingenberg

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04172012 (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), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 33% 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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. The Impact of COVID-19 Pandemic on ESBL-ProducingAntibiotics (Basel, Switzerland) · 2023
    Article
  7. 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

8 authors at 5 institutions in 2 countries.

Kanika KuwelkerNorwegian National Advisory Unit on Tropical Infectious Diseases, Haukeland University Hospital, Haukelandsbakken, 5009, Bergen, Norway. kkuwelker91@gmail.com.ORCID http://orcid.org/0000-0003-1302-950X
Nina LangelandNorwegian National Advisory Unit on Tropical Infectious Diseases, Haukeland University Hospital, Haukelandsbakken, 5009, Bergen, Norway.
Iren Høyland LöhrDepartment of Medical Microbiology, Stavanger University Hospital, Gerd Ragna Bloch Thorsens gate, 4011, Stavanger, Norway.
Joshua GidionDepartment of Paediatrics, Haydom Lutheran Hospital, Mbulu, Manyara, Tanzania.
Joel ManyahiDepartment of Clinical Science, University of Bergen, Laboratory Building, Haukeland University Hospital, Jonas Lies veg 87, 5021, Bergen, Norway.
Sabrina John MoyoDepartment of Clinical Science, University of Bergen, Laboratory Building, Haukeland University Hospital, Jonas Lies veg 87, 5021, Bergen, Norway.
Bjørn BlombergNorwegian National Advisory Unit on Tropical Infectious Diseases, Haukeland University Hospital, Haukelandsbakken, 5009, Bergen, Norway.
Claus KlingenbergDepartment of Paediatrics and Adolescence Medicine, University Hospital of North Norway, Tromsø, Norway.
Haukeland University Hospital · NOMuhimbili University of Health and Allied Sciences · TZHaydom Lutheran Hospital · TZStavanger University Hospital · NOUniversity Hospital of North Norway · NO

Funding

Helse Vest 912267
6 · The paper itself

Abstract

backgroundExtended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) has emerged as an urgent global health threat and is by the World Health Organization ranked as priority 1 among pathogens in need of new treatment. Studies have shown high mortality in Tanzanian children with ESBL-E infections. Gut colonization of ESBL-E, which is a potential risk factor of ESBL-E infections, is reported to be very high among children in Tanzania. Probiotics may potentially reduce gut colonization of multidrug-resistant bacteria. However, there is limited data on whether probiotics may reduce ESBL-E carriage in infants. The ProRIDE Trial aims to evaluate whether the use of probiotics can reduce morbidity and mortality among infants in Haydom, Tanzania, and whether this effect is associated with a reduction in ESBL-E colonization and/or infections. METHODS/

designThis large randomized double-blinded placebo-controlled trial aims to recruit 2000 newborn infants at Haydom Lutheran Hospital and the surrounding area in the period of November 2020 to November 2021. Participants will be enrolled from days 0 to 3 after birth and randomized to receive probiotics or placebo for 4 weeks. Participants will be followed-up for 6 months, during which three visits will be made to collect clinical and demographic information, as well as rectal swabs and fecal samples which will be subjected to laboratory analysis. The primary composite outcome is the prevalence of death and/or hospitalization at 6 months of age. DISCUSSION: As the use of probiotics may give a more favorable gut composition, and thereby improve health and reduce morbidity and mortality, the results may have implications for future therapy guidelines in Africa and internationally.

trial registrationClinicalTrials.gov NCT04172012. Registered on November 21, 2019.

Indexed as

Enterobacteriaceae InfectionsProbioticsAnti-Bacterial Agentsbeta-LactamasesChildEnterobacteriaceaeHumansInfantInfant, NewbornRandomized Controlled Trials as TopicTanzaniaAnti-Bacterial Agentsbeta-LactamasesEnterobacteriaceaeESBLExtended-spectrum beta-lactamaseGut colonizationHospitalizationInfant mortalityInfantsMicrobiotaNewbornProbioticsRandomized controlled trialResistome

Identifiers

PMID33926519
PMCPMC8082054
OpenAlexW3113915777

What OpenQuestion holds

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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.