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

NCT ID: NCT05952076

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-03
• Study Completion Date: 2024-01-29

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.

Conditions

Underweight; Paediatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Bi-26 supplementation

Bi-26 administered daily.

Group Type: EXPERIMENTAL

B. infantis Bi-26

Intervention Type: DIETARY_SUPPLEMENT

A once-daily oral dose of Bi-26 will be provided to infants for 28 days.

Placebo

Maltodextrin: Placebo administered daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

A once-daily oral dose of placebo maltodextrin will be provided to infants for 28 days

Interventions

B. infantis Bi-26

A once-daily oral dose of Bi-26 will be provided to infants for 28 days.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A once-daily oral dose of placebo maltodextrin will be provided to infants for 28 days

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 120 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gates Medical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gates MRI

Role: STUDY_DIRECTOR

Gates Medical Research Institute

Locations

Medical Facility A

Islamabad, Islamabad, Pakistan

Medical Facility B

Islamabad, Islamabad, Pakistan

Medical Facility C

Islamabad, Islamabad, Pakistan

Medical Facility

Lahore, Punjab Province, Pakistan

Medical Facility

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Gates MRI-MNK01-301

Identifier Type: -

Identifier Source: org_study_id