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
Abstract Background Extended-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...
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doaj-c3d99e2cf8c04022b5148c67a888008a2021-05-02T11:31:07ZengBMCTrials1745-62152021-04-0122111410.1186/s13063-021-05251-3Use 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 trialKanika Kuwelker0Nina Langeland1Iren Høyland Löhr2Joshua Gidion3Joel Manyahi4Sabrina John Moyo5Bjørn Blomberg6Claus Klingenberg7Norwegian National Advisory Unit on Tropical Infectious Diseases, Haukeland University HospitalNorwegian National Advisory Unit on Tropical Infectious Diseases, Haukeland University HospitalDepartment of Medical Microbiology, Stavanger University HospitalDepartment of Paediatrics, Haydom Lutheran HospitalDepartment of Clinical Science, University of Bergen, Laboratory Building, Haukeland University HospitalDepartment of Clinical Science, University of Bergen, Laboratory Building, Haukeland University HospitalNorwegian National Advisory Unit on Tropical Infectious Diseases, Haukeland University HospitalDepartment of Paediatrics and Adolescence Medicine, University Hospital of North NorwayAbstract Background Extended-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/design This 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 registration ClinicalTrials.gov NCT04172012. Registered on November 21, 2019https://doi.org/10.1186/s13063-021-05251-3NewbornInfantsProbioticsGut colonizationExtended-spectrum beta-lactamaseESBL |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Kanika Kuwelker Nina Langeland Iren Høyland Löhr Joshua Gidion Joel Manyahi Sabrina John Moyo Bjørn Blomberg Claus Klingenberg |
spellingShingle |
Kanika Kuwelker Nina Langeland Iren Høyland Löhr Joshua Gidion Joel Manyahi Sabrina John Moyo Bjørn Blomberg Claus Klingenberg 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 Trials Newborn Infants Probiotics Gut colonization Extended-spectrum beta-lactamase ESBL |
author_facet |
Kanika Kuwelker Nina Langeland Iren Høyland Löhr Joshua Gidion Joel Manyahi Sabrina John Moyo Bjørn Blomberg Claus Klingenberg |
author_sort |
Kanika Kuwelker |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-04-01 |
description |
Abstract Background Extended-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/design This 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 registration ClinicalTrials.gov NCT04172012. Registered on November 21, 2019 |
topic |
Newborn Infants Probiotics Gut colonization Extended-spectrum beta-lactamase ESBL |
url |
https://doi.org/10.1186/s13063-021-05251-3 |
work_keys_str_mv |
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