Nutritional, Metabolic, Endocrine Paediatrics
Conditions
Interventions
Infants receiving Placebo
Bifidobacterium longum subsp. infantis DSM33361 and Lacticaseibacillus rhamnosus GG DSM33156
Sponsors
Africa Clinical Research Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Participants are eligible to be included in the trial only if all of the following criteria apply: Age 1. Participant must be between 30 days and 120 days of age (inclusive), at the time of randomization (Day 1) Type of Participant and Disease Characteristics 2. Hospitalized for acute nonsurgical illness at screening or history of hospitalization for acute nonsurgical illness within 60 days prior to randomization • Definition of Hospitalization: For the purposes of this study, hospitalization is defined as admission to a hospital facility for a period of 24 hours or more, specifically for the management of an acute, non-surgical illness. 3. Completed fluid rehydration, pedal oedema (if present) has resolved, discharged from hospital, and no longer receiving antibiotics prior to randomization (Day 1) Weight 4. WAZ at randomization (Day 1) is greater than or equal to negative 4.5 and less than negative 2.0 (-4.5 = WAZ < -2.0) Sex 5. Any Informed consent 6. 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 Additional requirements 7. 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 8. Participant’s parent(s)/LAR is reliably able to store the investigational product under refrigerated conditions 9. Participant receives some feedings from breastmilk and mother intends to continue breast-feeding.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Participants are excluded from the trial if any of the following criteria apply: 1. Congenital condition (suspected or confirmed) that the Investigator considers likely to interfere with feeding or with normal growth and development (as per appendix 2) 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 invasive mechanical ventilation during current hospitalization 5. Infant with acute kidney injury on hospital admission 6. Infant with severe jaundice or suspected kernicterus 7. Infant with short bowel syndrome 8. Infant receiving treatment for suspected or confirmed HIV infection 9. Infants with suspected or confirmed TB infection at the time of screening or enrollment, regardless of treatment status 10. Ongoing or planned infant antibiotic (e.g., as prophylaxis in sickle cell disease) and/or probiotic usage 11. Ongoing or planned maternal antibiotic and/or probiotic usage for breast-feeding infants 12. Inability of participant’s parent(s)/LAR to comply with protocol requirements, as per Investigator assessment 13. Concurrent or planned participation in another clinical trial. 14. Infants who are part of a twin pair, where the other twin is also eligible for enrollment, will be excluded to prevent cross-contamination arising from shared living environments, feeding practices, physical contact, or caregiver-administered probiotics. 15. Participants whose primary residence is located at a distance that would impede the study team's ability to conduct required home visits and follow-up assessments, as determined by the research team, will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight-for-age Z score (WAZ) from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in weight (grams) from baseline;Outcome-Type continous. Outcome-WAZ change from baseline over time;Outcome type-Dichotomous.Outcome- Proportion of infants achieving WAZ > -2.0;Outcome Type: Dichotomous. Outcome: Proportion of infants achieving WAZ > -2.0;Outcome Type: Count/Rate. Outcome: Number of re-hospitalizations for acute non-surgical illness;Outcome Type: Safety (count). Outcome: Number of adverse events (AEs) and serious adverse events (SAEs);Outcome Type: Proportion. Outcome: Engraftment of B. infantis and/or L. rhamnosus in stool;Outcome Type: Economic. Outcome: Incremental cost-effectiveness ratio (ICER) per DALY averted; cost per patient per episode; total health system costs;Outcome Type: Equity. Outcome: Differential impacts by socioeconomic status and geographic location | — |
Countries
Kenya
Contacts
Public ContactPriscillah Cheruiyot
Site Manager MUCRC
Outcome results
None listed