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

2019/1025

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.

2022-02-01

2023-07-10

2024-12-31

Active (not recruiting)

Early phase I

2000

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled double-blinded randomized clinical trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Investigational product (probiotic) and placebo product have both been produced by the same manufacturer and is delivered in identical bottles.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2000, 'type': 'ACTUAL'}}

2023-12-12