Use of Probiotics to Reduce Infections, Death and ESBL Colonisation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-09-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neonatal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo-controlled double-blinded randomized clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Investigational product (probiotic) and placebo product have both been produced by the same manufacturer and is delivered in identical bottles.

Study Groups

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Probiotic

Study subjects receive probiotic mixture for 4 weeks

Group Type ACTIVE_COMPARATOR

Labinic (R) probiotic mixture

Intervention Type BIOLOGICAL

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

Placebo

Study subjects receive placebo mixture for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo mixture

Interventions

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Labinic (R) probiotic mixture

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

Intervention Type BIOLOGICAL

Placebo

Placebo mixture

Intervention Type OTHER

Eligibility Criteria

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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.