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

  • STATUS
    Recruiting
  • days left to enroll
    4
  • participants needed
    2000
  • sponsor
    Haydom Lutheran Hospital
Updated on 26 April 2022
Accepts healthy volunteers

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.

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.

Details
Condition Neonatal Sepsis
Treatment Placebo, Labinic (R) probiotic mixture
Clinical Study IdentifierNCT04172012
SponsorHaydom Lutheran Hospital
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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