Nutritional, Metabolic, Endocrine
Conditions
Interventions
Probiotics
Placebo
Sponsors
Africa Clinical Research Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant must be between 30 days and 120 days of age (inclusive), at the time of randomization (Day 1) Hospitalized for acute non-surgical illness at the time of screening Completed fluid rehydration, discharged from hospital, and no longer receiving antibiotics prior to randomization (Day 1) WAZ at randomization (Day 1) is less than negative 2 (<-2) Participant’s parent(s)/legally acceptable representative (LAR) is capable of giving informed consent which includes agreement to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Participant’s parent(s)/LAR agrees to stay in contact with the trial site for the duration of the trial, provide updated contact information as necessary, and have no current plans to relocate from the trial area for the duration of the trial Participant’s parent(s)/LAR is reliably able to store the investigational product under refrigerated conditions Participant receives some feedings from breastmilk and mother intends to continue breast-feeding.
Exclusion criteria
Exclusion criteria: Congenital condition (suspected or confirmed) that the Investigator considers likely to interfere with feeding or with normal growth and development Infant has not been discharged from hospital since birth or has not been at home for at least one week since birth Infant hospitalized with septic shock during current hospitalization Infant required mechanical ventilation during current hospitalization Infant with acute kidney injury on hospital admission Infant with severe jaundice or suspected kernicterus Infant with short bowel syndrome Infant receiving treatment for suspected tuberculosis or confirmed tuberculosis, or treatment for suspected or confirmed HIV infection Ongoing or planned infant antibiotic (e.g., as prophylaxis in sickle cell disease) and/or probiotic usage Ongoing maternal antibiotic and/or probiotic usage for breast-feeding infants Inability of participant’s parent(s)/LAR to comply with protocol requirements, as per Investigator assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WAZ change | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in weight (in grams) ;WAZ change from baseline;Proportion of infants with a = 0.3, = 0.4, and = 0.5 change in WAZ from baseline ;Proportion of infants who achieve a WAZ > -2 at Day 56 visit;Number of re-hospitalizations for acute non-surgical illness;Number of adverse events (AEs) and serious adverse events (SAEs);Proportion of infants with B. infantis and/or Lacticaseibacillus rhamnosus detected in stool on Days 1, 28, 56, and 90 post enrollment;Stool biomarkers on Days 1, 28, and 56 post enrollment;Blood biomarkers on Days 1 and 28 post enrollment | — |
Countries
Kenya, Zimbabwe
Contacts
Public ContactRomina Mariano
Chief of Staff Africa Clinical Research Network
Outcome results
None listed