A Phase 3 interventional study of B. infantis Bi-26 and Placebo in Underweight and Paediatrics, sponsored by Bill & Melinda Gates Medical Research Institute. Terminated at 5 sites in Pakistan. Open to participants aged 30 Days to 120 Days. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Bill & Melinda Gates Medical Research Institute · Phase 3, Interventional, and Other
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.
66 studies on the registry are indexed under Thinness; 11 are open to participants now.
This study's enrollment of 40 is below the median of 287 across 43 interventional studies indexed under Thinness.
Browse Thinness studies →Bill & Melinda Gates Medical Research Institute is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bi-26 administered daily.
Dietary Supplement: B. infantis Bi-26
Maltodextrin: Placebo administered daily
Dietary Supplement: Placebo
A once-daily oral dose of Bi-26 will be provided to infants for 28 days.
A once-daily oral dose of placebo maltodextrin will be provided to infants for 28 days
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.
Time frame: Baseline (Day 1) to Day 56
Change From Baseline in Weight to Day 56
Weight (grams) was summarized using descriptive statistics. Baseline (Day 1) was defined as the last available value prior to the participant receiving the first dose of the study intervention. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) to Day 56
Change From Baseline in WAZ Over Time Through Day 90
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.
Time frame: 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
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.
Time frame: Baseline (Day 1) to Day 56
Percentage of Participants Who Achieved a Score of WAZ > -2 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.
Time frame: At Day 56
Percentage of Participants Re-hospitalized
Hospitalizations are due to acute non-surgical illness. Percentage of participants re-hospitalized at Day 56 has been presented
Time frame: Baseline to Day 56
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE is considered treatment emergent if it started on or after the date of first dose of study intervention administration. Serious TEAE is any untoward medical occurrences at any dose of study medication that: results in death; is life threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect and is an important medical event.
Time frame: Up to Day 90
Percentage of Participants With Presence of B. Infantis in Stool
Stool samples were collected at defined time points to analyze the present of B.infantis.
Time frame: At Days 1, 28, 56 and 90
This was a Phase 3, randomized, double-blind study that evaluated the impact of Bi-26 (strain of Bifidobacterium longum, B. infantis) supplementation on weight gain in underweight infants.
| Milestone | Bi-26 Supplementation | Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 18 |
| Not completed | 1 | 2 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| Z-score | Bi-26 Supplementation | Placebo |
|---|---|---|
| Change From Baseline in Weight-for-age Z Score (WAZ) at Day 56 | 0.78 (0.39 to 1.17) | 0.67 (0.28 to 1.06) |
Weight (grams) was summarized using descriptive statistics. Baseline (Day 1) was defined as the last available value prior to the participant receiving the first dose of the study intervention. Change from Baseline was defined as post-dose visit value minus Baseline value.
| Grams | Bi-26 Supplementation | Placebo |
|---|---|---|
| Change From Baseline in Weight to Day 56 | 1491.47 (1233.45 to 1749.48) | 1382.17 (1123.95 to 1640.39) |
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.
| Z-score | Bi-26 Supplementation | Placebo |
|---|---|---|
| Change From Baseline in WAZ Over Time Through Day 90 | 1.09 (0.70 to 1.48) | 1.00 (0.60 to 1.39) |
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.
| Percentage of participants | Bi-26 Supplementation | Placebo |
|---|---|---|
| Increase of >= 0.3 units | 87.5 (64.5 to 97.8) | 64.3 (37.6 to 85.6) |
| Increase of >= 0.4 units | 87.5 (64.5 to 97.8) | 64.3 (37.6 to 85.6) |
| Increase of >= 0.5 units | 68.8 (43.7 to 87.5) | 64.3 (37.6 to 85.6) |
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.
| Percentage of participants | Bi-26 Supplementation | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved a Score of WAZ > -2 at Day 56 | 19 (5.0 to 43) | 14 (2.5 to 39.7) |
Hospitalizations are due to acute non-surgical illness. Percentage of participants re-hospitalized at Day 56 has been presented
| Percentage of participants | Bi-26 Supplementation | Placebo |
|---|---|---|
| Percentage of Participants Re-hospitalized | NA (NA to NA) | 20 (5.7 to 43.7) |
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE is considered treatment emergent if it started on or after the date of first dose of study intervention administration. Serious TEAE is any untoward medical occurrences at any dose of study medication that: results in death; is life threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect and is an important medical event.
| Participants | Bi-26 Supplementation | Placebo |
|---|---|---|
| Any TEAE | 8 | 16 |
| Any serious TEAE | 1 | 5 |
Stool samples were collected at defined time points to analyze the present of B.infantis.
| Percentage of participants | Bi-26 Supplementation | Placebo |
|---|---|---|
| Day 1 | 62.5 (37.6 to 83.2) | 50.0 (25.1 to 74.9) |
| Day 28 | 100.0 (82.9 to 100.0) | 57.1 (31.1 to 80.4) |
| Day 56 | 100.0 (82.9 to 100.0) | 57.1 (31.1 to 80.4) |
| Day 90 | 93.8 (72.8 to 99.7) | 57.1 (31.1 to 80.4) |
Collected over Up to 90 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bi-26 Supplementation | 1/20 (5%) | 1/20 (5%) | 7/20 (35%) |
| Placebo | 1/20 (5%) | 5/20 (25%) | 14/20 (70%) |
| Event | Bi-26 Supplementation | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 0/20 | 2/20 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/20 | 1/20 |
| PyrexiaGeneral disorders | 0/20 | 1/20 |
| Sudden deathGeneral disorders | 0/20 | 1/20 |
| MeningitisInfections and infestations | 0/20 | 1/20 |
| Otitis mediaInfections and infestations | 0/20 | 1/20 |
| Pneumonia measlesInfections and infestations | 0/20 | 1/20 |
| DeathGeneral disorders | 1/20 | 0/20 |
| Event | Bi-26 Supplementation | Placebo |
|---|---|---|
| VomitingGastrointestinal disorders | 4/20 | 8/20 |
| Abdominal painGastrointestinal disorders | 4/20 | 3/20 |
| DiarrhoeaGastrointestinal disorders | 1/20 | 3/20 |
| PyrexiaGeneral disorders | 0/20 | 3/20 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/20 | 3/20 |
| NasopharyngitisInfections and infestations | 1/20 | 2/20 |
| HydroceleCongenital, familial and genetic disorders | 0/20 | 1/20 |
| Abdominal distensionGastrointestinal disorders | 1/20 | 0/20 |
| AcarodermatitisInfections and infestations | 0/20 | 1/20 |
| BronchiolitisInfections and infestations | 0/20 | 1/20 |
Safety population comprised of all participants randomly assigned to study intervention, who received any dose, including a partial dose, of the study intervention.
| Age, Continuous(Days) | Bi-26 Supplementation | Placebo | Total |
|---|---|---|---|
| Mean | 57.6 ± 21.1 | 66.6 ± 23.6 | 62.1 ± 22.6 |
| Sex: Female, Male(Participants) | Bi-26 Supplementation | Placebo | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 10 | 10 | 20 |
| Race (NIH/OMB)(Participants) | Bi-26 Supplementation | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 20 | 20 | 40 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All IPD data that underlie results in a publication.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Ran from Jul 2023 to primary completion in Dec 2023, 5 months.
Results were first posted in Mar 2025, 1 year 2 months after primary completion.
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