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Sponsor decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bi-26 supplementation | Experimental | Bi-26 administered daily. |
|
| Placebo | Placebo Comparator | Maltodextrin: Placebo administered daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. infantis Bi-26 | Dietary Supplement | A once-daily oral dose of Bi-26 will be provided to infants for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) to Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gates MRI | Gates Medical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Facility A | Islamabad | Islamabad | 44000 | Pakistan | ||
| Medical Facility B |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42137872 | Derived | Parrino J, Sunshine J, Tripp K, Shaffer M, Sughra U, Prochazkova N, Jara M, Moll JM, Noble R, Muir L, McIntyre E, Guduk E, Zachariah D, Vernochet C, Frahm N, Schmidt AC. Impact of Bifidobacterium infantis supplementation on growth, health outcomes, and gut microbiome features in underweight infants from Pakistan. Front Nutr. 2026 Apr 29;13:1783141. doi: 10.3389/fnut.2026.1783141. eCollection 2026. |
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All IPD data that underlie results in a publication.
This will be done within 12months of the study completion date.
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.
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A total of 40 participants were enrolled from 1 country and were randomized 1:1 in experimental and placebo groups.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bi-26 Supplementation | Participants received Bi-26 supplementation once-daily orally for 28 days. |
| FG001 | Placebo | Participants received placebo (maltodextrin) once-daily orally for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population comprised of all participants randomly assigned to study intervention, who received any dose, including a partial dose, of the study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bi-26 Supplementation | Participants received Bi-26 supplementation once-daily orally for 28 days. |
| BG001 | Placebo | Participants received placebo (maltodextrin) once-daily orally for 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified Intention to Treat Population comprised of all participants randomly assigned to study intervention, who received any dose, including a partial dose of the study intervention. | Posted | Least Squares Mean | 95% Confidence Interval | Z-score | Baseline (Day 1) to Day 56 |
Up to 90 Days
TEAEs and serious AEs were collected in Safety Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bi-26 Supplementation | Participants received Bi-26 supplementation once-daily orally for 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (27.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Gates MRI | +1 857 702 2108 | clinical.trials@gatesmri.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2022 | Dec 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2023 | Dec 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013851 | Thinness |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | A once-daily oral dose of placebo maltodextrin will be provided to infants for 28 days |
|
| 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. | 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. | 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. | 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 | 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. | 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. | At Days 1, 28, 56 and 90 |
| Islamabad |
| Islamabad |
| 44000 |
| Pakistan |
| Medical Facility C | Islamabad | Islamabad | 44000 | Pakistan |
| Medical Facility | Lahore | Punjab Province | 54000 | Pakistan |
| Medical Facility | Rawalpindi | Punjab Province | 46000 | Pakistan |
| BG002 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Bi-26 Supplementation | Participants received Bi-26 supplementation once-daily orally for 28 days. |
| OG001 | Placebo | Participants received placebo (maltodextrin) once-daily orally for 28 days. |
|
|
|
| Secondary | 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. | Modified Intention to Treat Population. | Posted | Least Squares Mean | 95% Confidence Interval | Grams | Baseline (Day 1) to Day 56 |
|
|
|
|
| Secondary | 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. | Modified Intention to Treat Population | Posted | Least Squares Mean | 95% Confidence Interval | Z-score | Baseline (Day 1) to Day 90 |
|
|
|
|
| Secondary | 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. | Per-Protocol (PP) Population comprised of all participants randomly assigned to study intervention, who received the study intervention, have a Day 90 visit, and did not substantially deviate from the protocol procedures. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) to Day 56 |
|
|
|
| Secondary | 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. | PP Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Day 56 |
|
|
|
| Secondary | Percentage of Participants Re-hospitalized | Hospitalizations are due to acute non-surgical illness. Percentage of participants re-hospitalized at Day 56 has been presented | Safety Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Day 56 |
|
|
|
| Secondary | 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. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 90 |
|
|
|
| Secondary | 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. | PP Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Days 1, 28, 56 and 90 |
|
|
|
| 1 |
| 20 |
| 1 |
| 20 |
| 7 |
| 20 |
| EG001 | Placebo | Participants received placebo (maltodextrin) once-daily orally for 28 days. | 1 | 20 | 5 | 20 | 14 | 20 |
| Pyrexia | General disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Pneumonia measles | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Death | General disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Measles | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Non-systematic Assessment |
|
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| Increase of >= 0.5 units |
|
| Day 56 |
|
| Day 90 |
|