Clinical trial NCT05952076: Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Bi-26 (Strain of Bifidobacterium Longum, B. Infantis) Supplementation Versus Placebo on Weight Gain in Underweight Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Underweight
Paediatrics
Keywords: Weight-for-age Z score
Underweight infants
Bifidobacterium longum, B. infantis
Bi-26 supplementation
Lead sponsor: Bill & Melinda Gates Medical Research Institute
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The burden of disease experienced by underweight children is significant, particularly in low- and middle-income countries. Gut dysbiosis, an imbalance in microbial composition, is thought to play a role in nutrient malabsorption leading to underweight infants and failure to thrive. Bifidobacterium longum subspecies infantis (B. infantis) is a commensal bacterial strain important in the breakdown of human milk oligosaccharides (HMOs). A decrease in abundance or absence of B. infantis could lead to inadequate HMO processing, elevating intestinal pH and increasing the risk of pathogen overgrowth. Bi-26 is a B. infantis probiotic strain that is being evaluated in this study for its impact on weight gain and other health outcomes in underweight infants.


Eligibility criteria: Inclusion Criteria:

* Participant must be between 30 days and 120 days of age (inclusive), at the time of enrollment (study Day 1)
* Hospitalized for acute non-surgical illness
* Completed acute stabilization phase of treatment, including fluid rehydration and antibiotic course, prior to enrollment (study Day 1)
* WAZ at enrollment (study Day 1) is less than negative 2 (\<-2)
* Any sex
* 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 the protocol
* 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
* Participant's parent(s)/legal guardian has easy access to reliable refrigeration (for storage of investigational product)
* Participant receives some feedings from breastmilk and mother intends to continue breastfeeding.

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 and suspected kernicterus
* Infant receiving treatment for suspected or confirmed tuberculosis, or suspected or confirmed human immunodeficiency virus (HIV) infection
* Ongoing 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)/legal guardian to comply with protocol requirements, as per investigator assessment.

Primary outcomes:
measure: Change From Baseline in Weight-for-age Z Score (WAZ) at Day 56
timeFrame: Baseline (Day 1) to Day 56
Secondary outcomes:
measure: Change From Baseline in Weight to Day 56
timeFrame: Baseline (Day 1) to Day 56
measure: Change From Baseline in WAZ Over Time Through Day 90
timeFrame: Baseline (Day 1) to Day 90
measure: Percentage of Participants With a ≥ 0.3, ≥ 0.4, and ≥ 0.5 Change in WAZ From Baseline at Day 56
timeFrame: Baseline (Day 1) to Day 56
measure: Percentage of Participants Who Achieved a Score of WAZ > -2 at Day 56
timeFrame: At Day 56
measure: Percentage of Participants Re-hospitalized
timeFrame: Baseline to Day 56
measure: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: Up to Day 90
measure: Percentage of Participants With Presence of B. Infantis in Stool
timeFrame: At Days 1, 28, 56 and 90
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Medical Facility A
state: Islamabad Capital Territory
city: Islamabad
country: Pakistan
facility: Medical Facility B
state: Islamabad Capital Territory
city: Islamabad
country: Pakistan
facility: Medical Facility C
state: Islamabad Capital Territory
city: Lahore
country: Pakistan
facility: Medical Facility
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Medical Facility
state: Punjab
Study officials:
affiliation: Bill & Melinda Gates Medical Research Institute
name: Gates MRI
role: STUDY_DIRECTOR
References: