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

NCT05952076 | Terminated Phase 3 Results DMC

• 1 other identifier: Gates MRI-MNK01-301
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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

Keywords

Weight-for-age Z score; Underweight infants; Bifidobacterium longum, B. infantis; Bi-26 supplementation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weight-for-age Z Score (WAZ) at Day 56

  The Weight-for-Age Z-score (WAZ) is an anthropometric measure used to classify a child's nutritional status. The WAZ measures the number of standard deviations of a child's actual weight from the median weight of children of the same age based on the World Health Organization (WHO) child growth standards (reference population). WAZ of 0 represents the median weight for age in the reference population. WAZ ≥-3 to \<-2 standard deviations below the WHO child growth standards median is considered moderately underweight and WAZ \<-3 is considered severely underweight. Least Squares Mean, 95% Confidence Interval, and p-value was derived from mixed model repeated measures with treatment and visit as factors and baseline WAZ, baseline age (days), and study intervention compliance as covariates. The treatment\*visit interaction terms were included and used to estimate the adjusted mean difference in Change from Baseline in WAZ between Bi-26 and Placebo.

  Baseline (Day 1) to Day 56

Secondary Outcomes (7)

• Change From Baseline in Weight to Day 56

  Baseline (Day 1) to Day 56

• Change From Baseline in WAZ Over Time Through Day 90

  Baseline (Day 1) to Day 90

• Percentage of Participants With a ≥ 0.3, ≥ 0.4, and ≥ 0.5 Change in WAZ From Baseline at Day 56

  Baseline (Day 1) to Day 56

• Percentage of Participants Who Achieved a Score of WAZ > -2 at Day 56

  At Day 56

• Percentage of Participants Re-hospitalized

  Baseline to Day 56

Study Arms (2)

Bi-26 supplementation

EXPERIMENTAL

Bi-26 administered daily.

Dietary Supplement: B. infantis Bi-26

Placebo

PLACEBO COMPARATOR

Maltodextrin: Placebo administered daily

Dietary Supplement: Placebo

Interventions

B. infantis Bi-26 DIETARY_SUPPLEMENT

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

Bi-26 supplementation

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 30 Days - 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gates Medical Research Institute: lead

Study Sites (5)

Medical Facility A

Islamabad, Islamabad, 44000, Pakistan

Location

Medical Facility B

Islamabad, Islamabad, 44000, Pakistan

Location

Medical Facility C

Islamabad, Islamabad, 44000, Pakistan

Location

Medical Facility

Lahore, Punjab Province, 54000, Pakistan

Location

Medical Facility

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Thinness

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Gates MRI

clinical.trials@gatesmri.org

+1 857 702 2108

Study Officials

• Gates MRI

  Gates Medical Research Institute

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: July 3, 2023
• Primary Completion: December 26, 2023
• Study Completion: January 29, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: This will be done within 12months of the study completion date.
• Access Criteria: Anonymized participant level data may be shared with external researchers in accordance with the trial participants' written and executed informed consent document and any local or applicable regulations on data sharing. Qualified researchers may submit a request for anonymized participant level data along with a research proposal to Gates MRI for review. The types of supporting information that could be shared with external researchers include: the Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and analytic code. A data sharing agreement must be in place before any clinical trial data are shared. There are additional circumstances that may prevent the sharing of data with external researchers, including but not limited to contractual obligations to existing partners and any restrictions imposed by regulatory bodies.

Locations

PA (5)