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Use of Probiotics to Reduce Infections, Death and ESBL Colonisation (ProRIDE)

Primary Purpose

Neonatal Sepsis

Status
Recruiting
Phase
Phase 3
Locations
Tanzania
Study Type
Interventional
Intervention
Labinic (R) probiotic mixture
Placebo
Sponsored by
Haydom Lutheran Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Sepsis focused on measuring Tanzania, East Africa, Antimicrobial resistance, Probiotics, Extended Spectrum Beta-Lactamase Producing Bacteria

Eligibility Criteria

undefined - 3 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • Children less than one year admitted to hospital with suspected infection, not included in the RCT, will be included in a sub-study. A separate inclusion form is prepared for these children.

Exclusion Criteria:

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

Sites / Locations

  • Haydom Lutheran HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Study subjects receive probiotic mixture for 4 weeks

Study subjects receive placebo mixture for 4 weeks

Outcomes

Primary Outcome Measures

Composite outcome hospitalization and death
Primary outcome is hospitalization and/or death of study subject

Secondary Outcome Measures

ESBL colonization
Colonization with Extended-spectrum beta-lactamase-producing Enterobacteriaceae as detected by fecal swab

Full Information

First Posted
November 19, 2019
Last Updated
April 5, 2022
Sponsor
Haydom Lutheran Hospital
Collaborators
University of Bergen, Helse Stavanger HF, UiT The Arctic University of Norway, Muhimbili University of Health and Allied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04172012
Brief Title
Use of Probiotics to Reduce Infections, Death and ESBL Colonisation
Acronym
ProRIDE
Official Title
Use of Probiotics to Reduce Infections and Death and Prevent Colonization With Extended-spectrum Beta-lactamase Producing Bacteria, Among Newborn Infants in Haydom and Surrounding Area, Tanzania, a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haydom Lutheran Hospital
Collaborators
University of Bergen, Helse Stavanger HF, UiT The Arctic University of Norway, Muhimbili University of Health and Allied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Studies show that probiotics given to prematurely born babies prevents sepsis and is widely used in the western world for this purpose. Probiotics consists of one or more normal gut-bacteria. A large study in India showed that giving probiotics to full-born babies reduced hospitalizations and morbidity. This study investigates giving a probiotic mixture with different combination of bacteria, Lactobacillus acidophilus, Bifidobacterium infantis and Bifidobacterium breve, for a longer duration (4 weeks instead of 7 days). Infections with antibiotic-resistant bacteria is a major threat to health-care world-wide, and sepsis/severe infection caused by such bacteria is a major cause of neonatal death. The study hypothesis is that giving probiotics to newborns prevents them from getting colonized with antibiotic-resistant bacteria, such as Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-PE). By preventing colonization with ESBL-PE, severe infections such as sepsis may be prevented, and thereby survival may be improved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Sepsis
Keywords
Tanzania, East Africa, Antimicrobial resistance, Probiotics, Extended Spectrum Beta-Lactamase Producing Bacteria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Placebo-controlled double-blinded randomized clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigational product (probiotic) and placebo product have both been produced by the same manufacturer and is delivered in identical bottles.
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Study subjects receive probiotic mixture for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study subjects receive placebo mixture for 4 weeks
Intervention Type
Biological
Intervention Name(s)
Labinic (R) probiotic mixture
Intervention Description
Labinic (R) probiotic mixture containing Lactobacillus acidophilus and Bifidobacterium infantis and B. breve
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo mixture
Primary Outcome Measure Information:
Title
Composite outcome hospitalization and death
Description
Primary outcome is hospitalization and/or death of study subject
Time Frame
6 months from inclusion
Secondary Outcome Measure Information:
Title
ESBL colonization
Description
Colonization with Extended-spectrum beta-lactamase-producing Enterobacteriaceae as detected by fecal swab
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Children less than one year admitted to hospital with suspected infection, not included in the RCT, will be included in a sub-study. A separate inclusion form is prepared for these children. Exclusion Criteria: Birth weight below 2 kg Other health problems/illness, obvious congenital malformations. Parents not consenting
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Langeland, MD, PhD
Phone
+4741616450
Email
nina.langeland@uib.no
First Name & Middle Initial & Last Name or Official Title & Degree
Bjorn Blomberg, MD, PhD
Phone
+4793262119
Email
bjorn.blomberg@uib.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Langeland, MD, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haydom Lutheran Hospital
City
Babati
State/Province
Manyara
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua G Gidabayda, MD, MMed
Phone
+255784995669
Email
joggs_2003@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28813414
Citation
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. Erratum In: Nature. 2017 Nov 29;:
Results Reference
background
PubMed Identifier
30505830
Citation
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.
Results Reference
background
PubMed Identifier
27936054
Citation
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.
Results Reference
background
PubMed Identifier
33926519
Citation
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.
Results Reference
derived

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Use of Probiotics to Reduce Infections, Death and ESBL Colonisation

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