UnderweightPhase 3NCT05952076
Impact of Bi-26 Supplementation on Weight Gain in Underweight Infants
A Phase 3 study testing B. infantis Bi-26 in people with Underweight and Paediatrics, run by Gates Medical Research Institute at 5 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 120 days
- Conditions the study is for
- Underweight, Paediatrics
- What is being tested?
- B. infantis Bi-26
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 5 sitesPakistan
- Study dates
- 3 Jul 2023to 29 Jan 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Pakistan5 sites
Medical Facility A
Islamabad, Islamabad, 44000
Medical Facility B
Islamabad, Islamabad, 44000
Medical Facility C
Islamabad, Islamabad, 44000
Medical Facility
Lahore, Punjab Province, 54000
Medical Facility
Rawalpindi, Punjab Province, 46000
About this study
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
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
- Being tested
- B. infantis Bi-26, Placebo
- Keywords
- Weight-for-age Z score, Underweight infants, Bifidobacterium longum, B. infantis, Bi-26 supplementation
- Medical subject headings
- Thinness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. infantis Bi-26Dietary supplement
A once-daily oral dose of Bi-26 will be provided to infants for 28 days.
PlaceboDietary supplement
A once-daily oral dose of placebo maltodextrin will be provided to infants for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Bi-26 supplementation | Experimental | Bi-26 administered daily. Receives: Dietary Supplement: B. infantis Bi-26 |
| Placebo | Placebo comparator | Maltodextrin: Placebo administered daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) to Day 56
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At Days 1, 28, 56 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start3 Jul 2023
- Primary completion26 Dec 2023
- Study completion29 Jan 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UnderweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gates Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gates MRI, Study director, Gates Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952076
- Sponsor's protocol ID
- Gates MRI-MNK01-301
- Status last verified
- Feb 2025
- First submitted
- 11 Jul 2023
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD data that underlie results in a publication.
Publications
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.
PubMed 42137872
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05952076
- Acronym / sponsor ID
- Gates MRI-MNK01-301
- Conditions
- Underweight, Paediatrics
- Keywords
- Weight-for-age Z score, Underweight infants, Bifidobacterium longum, B. infantis, Bi-26 supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gates Medical Research InstituteUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-26 supplementation | Experimental | Dietary Supplement: B. infantis Bi-26Bi-26 administered daily. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin: Placebo administered daily |
Who may qualify
- Ages
- 30 to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B. infantis Bi-26A once-daily oral dose of Bi-26 will be provided to infants for 28 days. | Dietary supplement | Bi-26 supplementation |
| PlaceboA once-daily oral dose of placebo maltodextrin will be provided to infants for 28 days | Dietary supplement | Placebo |
Primary outcome
Change From Baseline in Weight-for-age Z Score (WAZ) at Day 56
Time frame: Baseline (Day 1) to 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.
7 secondary outcomes
Change From Baseline in Weight to Day 56
Time frame: Baseline (Day 1) to Day 56
Change From Baseline in WAZ Over Time Through Day 90
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
Time frame: Baseline (Day 1) to Day 56
Percentage of Participants Who Achieved a Score of WAZ > -2 at Day 56
Time frame: At Day 56
Percentage of Participants Re-hospitalized
Time frame: Baseline to Day 56
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Up to Day 90
Percentage of Participants With Presence of B. Infantis in Stool
Time frame: At Days 1, 28, 56 and 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42137872Parrino 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.
- Individual participant dataSharing planned: Yes. All IPD data that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gates MRI study director
Gates Medical Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing B. infantis Bi-26 in people with Underweight and Paediatrics, run by Gates Medical Research Institute at 5 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Weight-for-age Z Score (WAZ) at Day 56 (time frame: Baseline (Day 1) to Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05952076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.