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

Sponsor
Haydom Lutheran Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04172012
Collaborator
University of Bergen (Other), Helse Stavanger HF (Other), UiT The Arctic University of Norway (Other), Muhimbili University of Health and Allied Sciences (Other)
2,000
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
251.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Labinic (R) probiotic mixture
  • Other: Placebo
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Placebo-controlled double-blinded randomized clinical trialPlacebo-controlled double-blinded randomized clinical trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Investigational product (probiotic) and placebo product have both been produced by the same manufacturer and is delivered in identical bottles.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Probiotic

Study subjects receive probiotic mixture for 4 weeks

Biological: Labinic (R) probiotic mixture
Labinic (R) probiotic mixture containing Lactobacillus acidophilus and Bifidobacterium infantis and B. breve
Placebo Comparator: Placebo

Study subjects receive placebo mixture for 4 weeks

Other: Placebo
Placebo mixture

Outcome Measures

Primary Outcome Measures

  1. Composite outcome hospitalization and death [6 months from inclusion]

    Primary outcome is hospitalization and/or death of study subject

Secondary Outcome Measures

  1. ESBL colonization [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 3 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Haydom Lutheran Hospital Babati Manyara Tanzania

Sponsors and Collaborators

  • Haydom Lutheran Hospital
  • University of Bergen
  • Helse Stavanger HF
  • UiT The Arctic University of Norway
  • Muhimbili University of Health and Allied Sciences

Investigators

  • Principal Investigator: Nina Langeland, MD, PhD, University of Bergen

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Haydom Lutheran Hospital
ClinicalTrials.gov Identifier:
NCT04172012
Other Study ID Numbers:
  • 2019/1025
First Posted:
Nov 21, 2019
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Haydom Lutheran Hospital
Tanzania
East Africa
Antimicrobial resistance
Probiotics
Extended Spectrum Beta-Lactamase Producing Bacteria
Additional relevant MeSH terms:
Neonatal Sepsis

Study Results

No Results Posted as of Apr 12, 2022