Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants

Bill & Melinda Gates Medical Research Institute

Status and phase: Terminated; Phase 3

Conditions: Paediatrics; Underweight

Treatments: Dietary Supplement: Placebo; Dietary Supplement: B. infantis Bi-26

Study type: Interventional

Funder types: Other

Identifiers

NCT05952076

Gates MRI-MNK01-301

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 120 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Bi-26 supplementation

Experimental group

Description:

Bi-26 administered daily.

Treatment:

Dietary Supplement: B. infantis Bi-26

Placebo

Placebo Comparator group

Description:

Maltodextrin: Placebo administered daily

Treatment:

Dietary Supplement: Placebo