Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 17, 2025
Open Peer Review Period: Mar 19, 2025 - May 14, 2025
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Feasibility, safety and impact of the probiotics Lactiplantibacillus plantarum and Bifidobacterium in Papua New Guinean infants: methods and feasibility from a randomised controlled trial.
ABSTRACT
Background:
Childhood mortality in low- and middle-income countries (LMICs) remains a major public health concern, with infections being a leading cause of infant death. Probiotics have shown promise in reducing infection-related morbidity and mortality in preterm infants, but their use in full-term newborns in LMICs requires further investigation.
Objective:
This study aims to assess the feasibility, safety, and initial outcomes of administering one of two synbiotic formulations or a placebo to newborns in Papua New Guinea's Eastern Highlands Province.
Methods:
Between November 2020 and June 2023, healthy neonates (< 72 hours old, n=244) were randomly assigned in a double-blinded manner (1:1:1) to receive an oral preparation containing Lactiplantibacillus plantarum, Bifidobacterium longum subspecies infantis, or placebo for 7 consecutive days. Follow-up continued for 6 months, with rectal swabs, stool, blood, saliva, and/or nasopharyngeal swabs collected pre-intervention, on day 7, at 2 weeks, and at 1, 3, 4 and 6 months of age. Ongoing analyses will assess probiotic gut colonisation, bacterial nasopharyngeal carriage, antibody responses to Hib, Hepatitis B, PCV-13, and dTP, as well as hospitalisation and infection rates among intervention groups.
Results:
Funding and ethical approvals were obtained in 2018 and 2019. Initial synbiotic preparations were received in August 2020, with participant recruitment beginning in November 2020. All follow-up visits concluded in December 2023. Of the enroled infants, 218/244 (89%) completed the full 7-day synbiotic/placebo course, and 169/244 (69%) completed the study. Disruptions due to the COVID-19 pandemic led to family relocations outside the study area, preventing some infants from completing the study. High rates of sample collection were achieved, with >90% of rectal swabs, nasopharyngeal swabs, saliva, and blood samples successfully obtained at multiple time points. Sample analysis is ongoing.
Conclusions:
This study demonstrates that probiotic supplementation is feasible in full-term infants in an LMIC setting. The findings from this study will inform the need for larger trials of probiotics and synbiotics to complement existing efforts to reduce infection-related infant mortality in LMICs while also providing insights into their clinical, immunological, and microbiological impacts in infants. Clinical Trial: ANZCTR.org.au Identifier: CTRN12620001369910
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