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

Haydom Lutheran Hospital

Status and phase: Completed; Phase 3

Conditions: Neonatal Sepsis

Treatments: Other: Placebo; Biological: Labinic (R) probiotic mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT04172012

2019/1025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 patients

Sex: All

Ages: Under 3 days old

Volunteers: Accepts 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.
• Multiple pregnancy
• Parents not consenting

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,000 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Study subjects receive probiotic mixture for 4 weeks

Treatment:

Biological: Labinic (R) probiotic mixture

Placebo

Placebo Comparator group

Description:

Study subjects receive placebo mixture for 4 weeks

Treatment:

Other: Placebo