NCT04172012

Brief Summary

This study examines the effect of oral probiotic treatment to newborns on preventing hospitalizations, death and colonization with Extended-spectrum beta-lactamase-producing Gram negative bacteria. Half of the babies will receive 4 weeks treatment with an oral mixture of the probiotic Labinic (R) while the other half will receive a placebo mixture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
2.2 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2023

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

November 19, 2019

Last Update Submit

April 24, 2025

Conditions

Neonatal Sepsis

Keywords

TanzaniaEast AfricaAntimicrobial resistanceProbioticsExtended Spectrum Beta-Lactamase Producing Bacteria

Outcome Measures

Primary Outcomes (1)

  • Composite outcome hospitalization and death

    Primary outcome is hospitalization and/or death of study subject

    6 months from inclusion

Secondary Outcomes (12)

  • ESBL colonization

    6 weeks and 6 months

  • Hospitalisation

    6 weeks and 6 months

  • Death

    6 months

  • Body weight

    6 months

  • Body length

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Study subjects receive probiotic mixture for 4 weeks

Biological: Labinic (R) probiotic mixture

Placebo

PLACEBO COMPARATOR

Study subjects receive placebo mixture for 4 weeks

Other: Placebo

Interventions

Labinic (R) probiotic mixtureBIOLOGICAL

Labinic (R) probiotic mixture containing Lactobacillus acidophilus and Bifidobacterium infantis and B. breve

Probiotic
PlaceboOTHER

Placebo mixture

Placebo

Eligibility Criteria

AgeUp to 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy newborn infants with a birth weight equal or above 2.0 kgs, will be included in the study between 0-3 days of life.
  • Newborn infants have to come from families who are long-term or permanent residents in the defined catchment area for this trial (30 km radius from HLH) in Tanzania.
  • Parents are able and willing to complete study visit (including required study procedures) schedules over the six months proposed follow-up, which also includes hospitalizations required for compliance of this study protocol.
  • Parents agrees for the child not to participate in another study during the study period

You may not qualify if:

  • Birth weight below 2 kg
  • Other health problems/illness, obvious congenital malformations.
  • Multiple pregnancy
  • Parents not consenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydom Lutheran Hospital

Babati, Manyara Region, Tanzania

Location

Related Publications (6)

  • Panigrahi P, Parida S, Nanda NC, Satpathy R, Pradhan L, Chandel DS, Baccaglini L, Mohapatra A, Mohapatra SS, Misra PR, Chaudhry R, Chen HH, Johnson JA, Morris JG, Paneth N, Gewolb IH. A randomized synbiotic trial to prevent sepsis among infants in rural India. Nature. 2017 Aug 24;548(7668):407-412. doi: 10.1038/nature23480. Epub 2017 Aug 16.

    PMID: 28813414BACKGROUND

  • Esaiassen E, Hjerde E, Cavanagh JP, Pedersen T, Andresen JH, Rettedal SI, Stoen R, Nakstad B, Willassen NP, Klingenberg C. Effects of Probiotic Supplementation on the Gut Microbiota and Antibiotic Resistome Development in Preterm Infants. Front Pediatr. 2018 Nov 16;6:347. doi: 10.3389/fped.2018.00347. eCollection 2018.

    PMID: 30505830BACKGROUND

  • Tellevik MG, Blomberg B, Kommedal O, Maselle SY, Langeland N, Moyo SJ. High Prevalence of Faecal Carriage of ESBL-Producing Enterobacteriaceae among Children in Dar es Salaam, Tanzania. PLoS One. 2016 Dec 9;11(12):e0168024. doi: 10.1371/journal.pone.0168024. eCollection 2016.

    PMID: 27936054BACKGROUND

  • Moyo SJ, Justine M, Blomberg B, Lohr IH, Gideon J, Mdoe P, Mduma E, Manyahi J, Pettersen VK, Paschal J, Syre H, Bukhay R, Klingenberg C, Langeland N. Navigating the trials of a trial: lessons from ProRIDE on recruitment, retention, and follow-up in rural Africa. Trials. 2026 Jan 15. doi: 10.1186/s13063-026-09447-3. Online ahead of print.

    PMID: 41535953DERIVED

  • Klingenberg C, Justine M, Moyo SJ, Lohr IH, Gideon J, Mdoe P, Mduma E, Manyahi J, Bargheet A, Pettersen VK, Paschal J, Syre H, Bernhoff E, Bukhay R, Blomberg B, Langeland N. Home administration of a multistrain probiotic once per day for 4 weeks to newborn infants in Tanzania (ProRIDE): a double-blind, placebo-controlled randomised trial. Lancet Glob Health. 2025 Jun;13(6):e1082-e1090. doi: 10.1016/S2214-109X(25)00064-6.

    PMID: 40412397DERIVED

  • Kuwelker K, Langeland N, Lohr IH, Gidion J, Manyahi J, Moyo SJ, Blomberg B, Klingenberg C. 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.

    PMID: 33926519DERIVED

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nina Langeland, MD, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigational product (probiotic) and placebo product have both been produced by the same manufacturer and is delivered in identical bottles.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Placebo-controlled double-blinded randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

February 1, 2022

Primary Completion

July 10, 2023

Study Completion

September 19, 2023

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TA(1)