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Study protocol
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
Haukeland Universitetssjukehus
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1302-950X
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Background: Extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E) has emerged as an urgent global health threat, and is by 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 mediated through prevention of ESBL-E carriage.
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 day 0-3 after birth, and randomized to receive probiotics or placebo for four weeks. Participants will be followed up for six 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 six 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: www.clinicaltrials.gov , Trial identifier NCT04172012, Registered 21 November 2019
Keywords
Newborn, infants, probiotics, gut colonization, extended-spectrum beta-lactamase, ESBL, Enterobacteriaceae, infant mortality, hospitalization, microbiota, resistome
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CURRENT STATUS: Under Review
Version 1
Posted 21 Dec, 2020
No community comments so far
Review #1 received
Received 21 Jan, 2021
Reviewer #1 agreed
On 18 Jan, 2021
Reviewers invited
Invitations sent on 03 Jan, 2021
Editor assigned
On 21 Dec, 2020
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On 17 Dec, 2020
First submitted
On 31 Aug, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
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
Haukeland Universitetssjukehus
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1302-950X
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 21 Dec, 2020
No community comments so far
Review #1 received
Received 21 Jan, 2021
Reviewer #1 agreed
On 18 Jan, 2021
Reviewers invited
Invitations sent on 03 Jan, 2021
Editor assigned
On 21 Dec, 2020
Submission checks complete
On 17 Dec, 2020
First submitted
On 31 Aug, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E) has emerged as an urgent global health threat, and is by 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 mediated through prevention of ESBL-E carriage.
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 day 0-3 after birth, and randomized to receive probiotics or placebo for four weeks. Participants will be followed up for six 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 six 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: www.clinicaltrials.gov , Trial identifier NCT04172012, Registered 21 November 2019
Figure 1
Due to technical limitations, full-text HTML conversion of this manuscript could not be completed. However, the latest manuscript can be downloaded and accessed as a PDF.