Paediatrics
Conditions
Interventions
Bi26
Placebo
Sponsors
Bill and Melinda Gates Medical Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be between 30 days and 120 days of age (inclusive), at the time of enrollment (study Day 1) 2. Hospitalized for acute non-surgical illness 3. Completed acute stabilization phase of treatment, including fluid rehydration and antibiotic course, prior to enrollment (study Day 1) 4. WAZ at enrollment (study Day 1) is less than negative 2 (<-2) 5. Any sex 6. Participant’s parent(s)/legal guardian 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 7. Participant’s parent(s)/legal guardian agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to relocate from the study area for the duration of the study 8. Participant’s parent(s)/legal guardian has easy access to reliable refrigeration (for storage of investigational product) 9. Participant receives some feedings from breastmilk and mother intends to continue breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Congenital condition (suspected or confirmed) that the investigator considers likely to interfere with feeding or with normal growth and development 2. Infant has not been discharged from hospital since birth or has not been at home for at least one week since birth 3. Infant hospitalized with septic shock during current hospitalization 4. Infant required mechanical ventilation during current hospitalization 5. Infant with acute kidney injury on hospital admission 6. Infant with severe jaundice and suspected kernicterus 7. Infant receiving treatment for suspected or confirmed tuberculosis, or suspected or confirmed HIV infection 8. Ongoing infant antibiotic (e.g. as prophylaxis in sickle cell disease) and/or probiotic usage 9. Ongoing maternal antibiotic and/or probiotic usage for breast-feeding infants 10. Inability of participant’s parent(s)/legal guardian to comply with protocol requirements, as per investigator assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the change in weight (standardized for age) of infants receiving Bi-26. WAZ change from baseline (Day 1) to the Day 56 visit in Bi-26 group. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the change in weight of infants receiving Bi-26. Change in weight (in grams) from baseline (Day 1) to the Day 56 visit in the Bi-26 group.;To estimate the treatment response over time associated with Bi-26. WAZ change from baseline (Day 1) over time through the Day 90 visit (longitudinal assessment) by duration of dosing;To assess the proportion of infants who achieve a specified change in WAZ from baseline to Day 56. Proportion of infants with a = 0.3, = 0.4, and = 0.5 change in WAZ from baseline (Day 1) to Day 56 visit;To assess the proportion of infants who achieve a specified WAZ at Day 56. Proportion of infants who achieve a WAZ > -2 at Day 56 visit.;To assess the re-hospitalization rate. Number of re-hospitalizations for acute non-surgical illness through the Day 56 visit.;To assess the safety of Bi-26 supplementation through End of Study (EoS, Day 90 visit). Number of adverse events (AEs) and serious adverse events (SAEs) through Day 90.;To measure engraftment of B. infantis in participants. Presence of B. infantis in stool on Days 1, 28, 56, and 90 | — |
Countries
Kenya, Tanzania
Contacts
Public ContactMichelle Botha
Associate Director RSU
Outcome results
None listed