Suspended

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

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What is being tested

B. infantis Bi-26

+ Placebo

Dietary Supplement
Who is being recruted

Body Weight+1

+ Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-ControlledPhase 3
Interventional
Study Start: July 2023
See protocol details

Summary

Principal SponsorGates Medical Research Institute
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 3, 2023

Actual date on which the first participant was enrolled.

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.

Official TitleA 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
NCT05952076
Principal SponsorGates Medical Research Institute
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Criteria

9 inclusion criteria required to participate
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)
Show More Criteria
10 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Bi-26 administered daily.

Group II

Placebo
Maltodextrin: Placebo administered daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Medical Facility A

Islamabad, PakistanOpen Medical Facility A in Google Maps
Suspended

Medical Facility B

Islamabad, Pakistan
Suspended

Medical Facility C

Islamabad, Pakistan
Suspended

Medical Facility

Lahore, Pakistan
Suspended5 Study Centers