Back to resultsImpact of Bi-26 Supplementation on Weight Gain in Underweight Infants
Primary Purpose
Underweight, Paediatrics
Status
Recruiting
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
B. infantis Bi-26
Placebo
Sponsored by
About this trial
This is an interventional other trial for Underweight focused on measuring Weight-for-age Z score, Underweight infants, Bifidobacterium longum, B. infantis, Bi-26 supplementation
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.
Sites / Locations
- Medical FacilityRecruiting
- Medical FacilityRecruiting
- Medical FacilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bi-26 supplementation
Placebo
Arm Description
Bi-26 administered daily.
Maltodextrin: Placebo administered daily
Outcomes
Primary Outcome Measures
Change from Baseline in Weight-for-age Z score (WAZ) to Day 56 visit in Bi-26 group
Weight for age Z score will be calculated using the World Health Organization standard reference tables. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean.
Secondary Outcome Measures
Change from Baseline in weight to Day 56 visit in Bi-26 group
Change from Baseline in WAZ over time through Day 90 visit in Bi-26 group by duration of dosing
Percentage of infants with a ≥ 0.3, ≥ 0.4, and ≥ 0.5 change in WAZ from Baseline to Day 56
Percentage of infants who will achieve a WAZ > -2 at Day 56
Number of re-hospitalizations for acute non-surgical illness
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with presence of B. infantis in stool
Full Information
NCT ID
NCT05952076
First Posted
July 11, 2023
Last Updated
August 11, 2023
Sponsor
Bill & Melinda Gates Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05952076
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
March 16, 2024 (Anticipated)
Study Completion Date
April 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bill & Melinda Gates Medical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underweight, Paediatrics
Keywords
Weight-for-age Z score, Underweight infants, Bifidobacterium longum, B. infantis, Bi-26 supplementation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
396 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bi-26 supplementation
Arm Type
Experimental
Arm Description
Bi-26 administered daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin: Placebo administered daily
Intervention Type
Dietary Supplement
Intervention Name(s)
B. infantis Bi-26
Intervention Description
A once-daily oral dose of Bi-26 will be provided to infants for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
A once-daily oral dose of placebo maltodextrin will be provided to infants for 28 days
Primary Outcome Measure Information:
Title
Change from Baseline in Weight-for-age Z score (WAZ) to Day 56 visit in Bi-26 group
Description
Weight for age Z score will be calculated using the World Health Organization standard reference tables. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean.
Time Frame
Baseline (Day 1) and up to Day 56 visit
Secondary Outcome Measure Information:
Title
Change from Baseline in weight to Day 56 visit in Bi-26 group
Time Frame
Baseline (Day 1) and up to Day 56 vist
Title
Change from Baseline in WAZ over time through Day 90 visit in Bi-26 group by duration of dosing
Time Frame
Baseline (Day 1) and up to Day 90 visit
Title
Percentage of infants with a ≥ 0.3, ≥ 0.4, and ≥ 0.5 change in WAZ from Baseline to Day 56
Time Frame
Baseline (Day 1) and up to Day 56 visit
Title
Percentage of infants who will achieve a WAZ > -2 at Day 56
Time Frame
Baseline (Day 1) and up to Day 56 visit
Title
Number of re-hospitalizations for acute non-surgical illness
Time Frame
Baseline (Day 1) and up to Day 56 visit
Title
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Baseline (Day 1) through Day 90 visit
Title
Number of participants with presence of B. infantis in stool
Time Frame
At randomization (Day 1), and at Days 28, 56 and Day 90 visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gates MRI
Phone
+1 857 702 2108
Email
clinical.trials@gatesmri.org
First Name & Middle Initial & Last Name or Official Title & Degree
Gates MRI (Toll Free Number)
Phone
+1 866 789 5767
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gates MRI
Organizational Affiliation
Bill & Melinda Gates Medical Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Medical Facility
City
Islamabad
State/Province
Islamabad Capital Territory
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Medical Facility
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD data that underlie results in a publication.
IPD Sharing Time Frame
This will be done within 12months of the study completion date.
IPD Sharing 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.
Learn more about this trial
Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants
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