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

doi:10.1186/s13063-021-05251-3

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

Research output: Contribution to journal › Article › peer-review

7 Citations (Scopus)

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.

Original language	English
Article number	312
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05251-3
Publication status	Published - 29 Apr 2021
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Enterobacteriaceae
ESBL
Extended-spectrum beta-lactamase
Gut colonization
Hospitalization
Infant mortality
Infants
Microbiota
Newborn
Probiotics
Randomized controlled trial
Resistome

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Kuwelker, K., Langeland, N., Löhr, I. H., Gidion, J., Manyahi, J., Moyo, S. J., Blomberg, B., & Klingenberg, C. (2021). 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, 22(1), Article 312. https://doi.org/10.1186/s13063-021-05251-3

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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",

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.",

keywords = "Enterobacteriaceae, ESBL, Extended-spectrum beta-lactamase, Gut colonization, Hospitalization, Infant mortality, Infants, Microbiota, Newborn, Probiotics, Randomized controlled trial, Resistome",

author = "Kanika Kuwelker and Nina Langeland and L{\"o}hr, \{Iren H{\o}yland\} and Joshua Gidion and Joel Manyahi and Moyo, \{Sabrina John\} and Bj{\o}rn Blomberg and Claus Klingenberg",

year = "2021",

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doi = "10.1186/s13063-021-05251-3",

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Kuwelker, K, Langeland, N, Löhr, IH, Gidion, J, Manyahi, J, Moyo, SJ, Blomberg, B & Klingenberg, C 2021, '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, vol. 22, no. 1, 312. https://doi.org/10.1186/s13063-021-05251-3

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. / Kuwelker, Kanika; Langeland, Nina; Löhr, Iren Høyland et al.
In: Trials, Vol. 22, No. 1, 312, 29.04.2021.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

AU - Kuwelker, Kanika

AU - Langeland, Nina

AU - Löhr, Iren Høyland

AU - Gidion, Joshua

AU - Manyahi, Joel

AU - Moyo, Sabrina John

AU - Blomberg, Bjørn

AU - Klingenberg, Claus

PY - 2021/4/29

Y1 - 2021/4/29

N2 - 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.

AB - 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.

KW - Enterobacteriaceae

KW - ESBL

KW - Extended-spectrum beta-lactamase

KW - Gut colonization

KW - Hospitalization

KW - Infant mortality

KW - Infants

KW - Microbiota

KW - Newborn

KW - Probiotics

KW - Randomized controlled trial

KW - Resistome

U2 - 10.1186/s13063-021-05251-3

DO - 10.1186/s13063-021-05251-3

M3 - Article

C2 - 33926519

AN - SCOPUS:85105127419

SN - 1745-6215

VL - 22

JO - Trials

JF - Trials

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ER -

Kuwelker K, Langeland N, Löhr IH, Gidion J, Manyahi J, Moyo SJ et al. 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. 2021 Apr 29;22(1):312. doi: 10.1186/s13063-021-05251-3