Healthy ChildrenPhase 2NCT07490587
To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
A Phase 2 study testing Probiotic in people with Healthy Children, run by Min-Tze LIONG at 2 sites in 2 countries.
Trial summary
This study is a 180-day randomized, double-blind, placebo-controlled trial involving healthy infants and young children under 3 years of age with elevated allergy risk. Participants are randomized to receive either Bifidobacterium animalis subsp. lactis XLTG11 probiotic or placebo daily. Read more about this study
- Who is it for?
- Ages 0 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2024to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 0 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infants are 37≤ gestational age < 42 weeks, and the birth weight is between 2500g and 4000g (only applicable to 0~12 months old)
- Breastfed or mixed-fed healthy infants and young children, aged 0~3 (inclusive) years old, gender is not limited
- The allergy risk score calculated by the Infant Allergy Risk Assessment Table is ≥6(Refer to the National Center for Women and Children's Health, Chinese Center for Disease Control and Prevention: Investigation and Research on Allergy Symptoms and Risk Factors in Infants and Young Children)
- Family primary guardians agree to collect fecal samples of infants and young children during this study
- Have not used antibiotics in the past month
- Have not used probiotics in the past three months
Show all 9Show fewer
- Family primary guardians committed not to add additional Bifidobacterium dietary supplements to infants and young children during the intervention period
- The guardians of the enrolled subjects agree to participate in this interventional study and sign a written informed consent form, and are able to understand and fill in forms such as infant diaries as required
- Signed informed consent and willing to follow up at the time specified in the trial
Who cannot join
- The mother of the infant has a history of diabetes, hepatitis B, HIV and other infectious diseases
- Clinicians diagnosed with allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) at the time of enrollment of infants and young children
- Infants and young children who are known to be allergic to the ingredients of probiotic products
- In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Jie Yuan, M.Sc. contact
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Pudong, Shanghai Municipality, 201306
Jinping Zhang, MD, 86 21-64369181, zhang-jin-ping@163.com
Jie Yuan, MD, 822137027899, peanut.yuan@diprobio.com
Malaysia1 site, 1 recruiting
- Not yet recruiting
Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, 11800
Min Tze Liong, Ph.D., 6046532114, mintze.liong@usm.my
Jie Yuan, MD, 822137027899, peanut.yuan@diprobio.com
About this study
This study is a 180-day randomized, double-blind, placebo-controlled trial involving healthy infants and young children under 3 years of age with elevated allergy risk. Participants are randomized to receive either Bifidobacterium animalis subsp. lactis XLTG11 probiotic or placebo daily. The primary clinical outcomes assessed are incidence and day-level burden of allergic, respiratory, and gastrointestinal symptoms. To investigate potential mechanisms, fecal samples were collected pre- and post-intervention for shotgun metagenomic sequencing to analyze changes in gut microbiota composition, functional pathways (KEGG, COG, GO), and mucosal immune markers (β-defensin 2, LL-37, calprotectin, sIgA) associated with clinical improvements.
Read the detailed description
Early childhood represents a critical developmental window during which the gut microbiome, immune system, and mucosal defense pathways undergo coordinated maturation. Dysregulation during this period contributes substantially to allergic sensitization, respiratory morbidity, and gastrointestinal disorders, which collectively represent major pediatric health burdens worldwide. Infants and young children frequently experience high symptom burden across these domains, reflecting vulnerability to microbial instability and disrupted mucosal homeostasis. The underlying causes are multifactorial, involving dietary transitions, environmental exposures, infections, and immune programming. Growing evidence suggests that disruptions in gut microbial stability, rather than merely compositional changes, may influence susceptibility to multi-system symptoms through interconnected immune and metabolic pathways.
The gastrointestinal tract and respiratory tract are interconnected components of the common mucosal immune system. Immune responses generated in the gut-associated lymphoid tissue can influence distant mucosal sites, including the respiratory epithelium and skin-associated lymphoid tissues. Probiotics can stimulate gut-associated lymphoid tissue, leading to enhanced production of antimicrobial peptides (β-defensin 2, LL-37), immunoglobulins, cytokines, and short-chain fatty acids. These immune mediators circulate systemically and contribute to strengthened epithelial barrier function and immune surveillance at multiple sites. In addition, maintaining functional stability of the gut microbial ecosystem, rather than simply increasing diversity, may be essential for safeguarding against stress-driven metabolic reprogramming and pathobiont expansion during early life.
Children affected by allergic, respiratory, and gastrointestinal symptoms often exhibit instability in microbial community architecture, including bloom of opportunistic taxa (Escherichia coli, Klebsiella, Enterococcus faecalis, Ruminococcus gnavus, Ruminococcus torques) and depletion of short-chain fatty acid-producing fermenters (Eubacterium rectale, Anaerostipes hadrus, Coprococcus species). Dysbiosis and functional instability weaken both local and systemic immunity, particularly through reduced production of antimicrobial peptides and impaired epithelial barrier function. Probiotic supplementation with Bifidobacterium animalis subsp. lactis XLTG11 may help restore microbial functional homeostasis, suppress pathobiont-associated trajectories, and enhance the host's innate mucosal defense profile.
Based on current scientific understanding, this 180-day randomized controlled trial enrolled healthy infants and young children under 3 years of age with elevated allergy risk. Participants received daily Bifidobacterium animalis subsp. lactis XLTG11 (1 × 10¹⁰ CFU) or placebo to evaluate clinical benefits across allergic, respiratory, and gastrointestinal domains, as well as safety outcomes including growth parameters and bowel habits. Additionally, shotgun metagenomic sequencing was performed on fecal samples collected at baseline and 180 days to assess changes in gut microbiota composition, taxonomic remodeling, KEGG pathways, KEGG enrichment patterns, COG functional profiles, and Gene Ontology terms. Mucosal innate immune markers (β-defensin 2, LL-37, calprotectin, secretory IgA) were quantified to assess host immune modulation.
Through these integrated clinical, immunological, and multi-omic metagenomic measures, the study aims to clarify whether B. animalis subsp. lactis XLTG11 reduces symptom burden by buffering against microbiome functional instability, preserving genomic and metabolic homeostasis, reinforcing epithelial innate defense, and suppressing pathobiont emergence-rather than by driving compositional expansion alone. This functional buffering mechanism represents a novel paradigm for probiotic action during the critical early-life window of immune and microbiome development.
- Conditions
- Healthy Children
- Being tested
- Probiotic, Placebo
- Keywords
- children, probiotic, allergy, bifidobacterium
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient
PlaceboDietary supplement
One sachet daily (2g) containing only maltodextrin as excipient
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | One sachet daily (2 g) containing only maltodextrin as excipient Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergy symptoms in children upon administration of probiotic or placebo as assessed via clinical questionnaire
Differences in severity of allergy symptoms in children upon administration of probiotic or placebo, assessed using a hospital-based clinical questionnaire, that captures the frequency and duration of symptoms over the observation period, where composite scores is the cumulative number and duration of reported episodes, with lower values indicating a lower overall symptom burden and better respiratory status.
Measured: Day-0, Day-180
Secondary outcomes (5)
Microbiota profiles of fecal samples in young children upon administration of probiotic or placebo as assessed via 16s rRNA and metagenomics gene sequencing
Differences in microbiota profiles in fecal sample of children upon administration of probiotic or placebo
Measured: Day-0, day-180
Gut immune biomarkers of fecal samples in young children upon administration of probiotic or placebo as assessed via Enzyme-Linked Immunosorbent Assay (ELISA)
Differences in gut immune biomarkers in fecal sample of children upon administration of probiotic or placebo, such as secretory immunoglobulin A (sIgA).
Measured: Day-0, Day-180
Defecation frequency in children upon administration of probiotic or placebo as assessed via daily stool diary
Differences in defecation frequency (stools per day) in children upon administration of probiotic or placebo, assessed using a structured daily stool diary completed by parents/guardians.
Measured: Day-0, day-180
Stool consistency (Bristol Stool Scale characteristics) in children upon administration of probiotic or placebo as assessed via standardized stool form classification
Differences in stool consistency in children upon administration of probiotic or placebo, assessed using the Bristol Stool Form Scale (type 1-7), with parents/guardians recording daily stool characteristics, where abnormal stools are characterized by types 1-2 (constipation) and types 6-7 (diarrhea).
Measured: Day-0, Day-180
Growth index (age- and sex-standardized Z-score) in children upon administration of probiotic or placebo as assessed via anthropometric measurements.
Differences in growth outcomes between groups were assessed using standardized anthropometric measurements where Z-scores are calculated based on the World Health Organization Child Growth Standards, and the scores represent standardized deviations from the reference population mean, with a theoretical range typically spanning approximately -6 to +6, where higher values indicate greater growth relative to age- and sex-specific norms.
Measured: Day-0, Day-180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ChildrenStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Jinping Zhang, MD, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490587
- Sponsor's protocol ID
- 2023-142
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yuan Y, Yin X, Liu J, Jing J, Shi Y, Tao S, Guo L, Wang D, Jiang W, Liong MT, Chen D, Zhang J. Bifidobacterium lactis XLTG11 Reduces Eczema and Infections in Infants: A Randomized Trial. QJM. 2026 Jun 17:hcag148. doi: 10.1093/qjmed/hcag148. Online ahead of print.
PubMed 42308545
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
- ClinicalTrials.gov ID
- NCT07490587
- Acronym / sponsor ID
- 2023-142
- Conditions
- Healthy Children
- Keywords
- children, probiotic, allergy, bifidobacterium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 180-day randomized, double-blind, placebo-controlled trial involving healthy infants and young children under 3 years of age with elevated allergy risk. Participants are randomized to receive either Bifidobacterium animalis subsp. lactis XLTG11 probiotic or placebo daily. The primary clinical outcomes assessed are incidence and day-level burden of allergic, respiratory, and gastrointestinal symptoms. To investigate potential mechanisms, fecal samples were collected pre- and post-intervention for shotgun metagenomic sequencing to analyze changes in gut microbiota composition, functional pathways (KEGG, COG, GO), and mucosal immune markers (β-defensin 2, LL-37, calprotectin, sIgA) associated with clinical improvements.
Detailed description
Early childhood represents a critical developmental window during which the gut microbiome, immune system, and mucosal defense pathways undergo coordinated maturation. Dysregulation during this period contributes substantially to allergic sensitization, respiratory morbidity, and gastrointestinal disorders, which collectively represent major pediatric health burdens worldwide. Infants and young children frequently experience high symptom burden across these domains, reflecting vulnerability to microbial instability and disrupted mucosal homeostasis. The underlying causes are multifactorial, involving dietary transitions, environmental exposures, infections, and immune programming. Growing evidence suggests that disruptions in gut microbial stability, rather than merely compositional changes, may influence susceptibility to multi-system symptoms through interconnected immune and metabolic pathways.
The gastrointestinal tract and respiratory tract are interconnected components of the common mucosal immune system. Immune responses generated in the gut-associated lymphoid tissue can influence distant mucosal sites, including the respiratory epithelium and skin-associated lymphoid tissues. Probiotics can stimulate gut-associated lymphoid tissue, leading to enhanced production of antimicrobial peptides (β-defensin 2, LL-37), immunoglobulins, cytokines, and short-chain fatty acids. These immune mediators circulate systemically and contribute to strengthened epithelial barrier function and immune surveillance at multiple sites. In addition, maintaining functional stability of the gut microbial ecosystem, rather than simply increasing diversity, may be essential for safeguarding against stress-driven metabolic reprogramming and pathobiont expansion during early life.
Children affected by allergic, respiratory, and gastrointestinal symptoms often exhibit instability in microbial community architecture, including bloom of opportunistic taxa (Escherichia coli, Klebsiella, Enterococcus faecalis, Ruminococcus gnavus, Ruminococcus torques) and depletion of short-chain fatty acid-producing fermenters (Eubacterium rectale, Anaerostipes hadrus, Coprococcus species). Dysbiosis and functional instability weaken both local and systemic immunity, particularly through reduced production of antimicrobial peptides and impaired epithelial barrier function. Probiotic supplementation with Bifidobacterium animalis subsp. lactis XLTG11 may help restore microbial functional homeostasis, suppress pathobiont-associated trajectories, and enhance the host's innate mucosal defense profile.
Based on current scientific understanding, this 180-day randomized controlled trial enrolled healthy infants and young children under 3 years of age with elevated allergy risk. Participants received daily Bifidobacterium animalis subsp. lactis XLTG11 (1 × 10¹⁰ CFU) or placebo to evaluate clinical benefits across allergic, respiratory, and gastrointestinal domains, as well as safety outcomes including growth parameters and bowel habits. Additionally, shotgun metagenomic sequencing was performed on fecal samples collected at baseline and 180 days to assess changes in gut microbiota composition, taxonomic remodeling, KEGG pathways, KEGG enrichment patterns, COG functional profiles, and Gene Ontology terms. Mucosal innate immune markers (β-defensin 2, LL-37, calprotectin, secretory IgA) were quantified to assess host immune modulation.
Through these integrated clinical, immunological, and multi-omic metagenomic measures, the study aims to clarify whether B. animalis subsp. lactis XLTG11 reduces symptom burden by buffering against microbiome functional instability, preserving genomic and metabolic homeostasis, reinforcing epithelial innate defense, and suppressing pathobiont emergence-rather than by driving compositional expansion alone. This functional buffering mechanism represents a novel paradigm for probiotic action during the critical early-life window of immune and microbiome development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticOne sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne sachet daily (2 g) containing only maltodextrin as excipient |
Who may qualify
- Ages
- 0 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Term infants are 37≤ gestational age < 42 weeks, and the birth weight is between 2500g and 4000g (only applicable to 0~12 months old)
- Breastfed or mixed-fed healthy infants and young children, aged 0~3 (inclusive) years old, gender is not limited
- The allergy risk score calculated by the Infant Allergy Risk Assessment Table is ≥6(Refer to the National Center for Women and Children's Health, Chinese Center for Disease Control and Prevention: Investigation and Research on Allergy Symptoms and Risk Factors in Infants and Young Children)
- Family primary guardians agree to collect fecal samples of infants and young children during this study
- Have not used antibiotics in the past month
Key exclusion criteria (4 listed)
- The mother of the infant has a history of diabetes, hepatitis B, HIV and other infectious diseases
- Clinicians diagnosed with allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) at the time of enrollment of infants and young children
- Infants and young children who are known to be allergic to the ingredients of probiotic products
- In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study
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 |
|---|---|---|
| ProbioticOne sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient | Dietary supplement | Probiotic |
| PlaceboOne sachet daily (2g) containing only maltodextrin as excipient | Dietary supplement | Placebo |
Primary outcome
Allergy symptoms in children upon administration of probiotic or placebo as assessed via clinical questionnaire
Time frame: Day-0, Day-180
Differences in severity of allergy symptoms in children upon administration of probiotic or placebo, assessed using a hospital-based clinical questionnaire, that captures the frequency and duration of symptoms over the observation period, where composite scores is the cumulative number and duration of reported episodes, with lower values indicating a lower overall symptom burden and better respiratory status.
5 secondary outcomes
Microbiota profiles of fecal samples in young children upon administration of probiotic or placebo as assessed via 16s rRNA and metagenomics gene sequencing
Time frame: Day-0, day-180
Gut immune biomarkers of fecal samples in young children upon administration of probiotic or placebo as assessed via Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: Day-0, Day-180
Defecation frequency in children upon administration of probiotic or placebo as assessed via daily stool diary
Time frame: Day-0, day-180
Stool consistency (Bristol Stool Scale characteristics) in children upon administration of probiotic or placebo as assessed via standardized stool form classification
Time frame: Day-0, Day-180
Growth index (age- and sex-standardized Z-score) in children upon administration of probiotic or placebo as assessed via anthropometric measurements.
Time frame: Day-0, Day-180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 42308545Yuan Y, Yin X, Liu J, Jing J, Shi Y, Tao S, Guo L, Wang D, Jiang W, Liong MT, Chen D, Zhang J. Bifidobacterium lactis XLTG11 Reduces Eczema and Infections in Infants: A Randomized Trial. QJM. 2026 Jun 17:hcag148. doi: 10.1093/qjmed/hcag148. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Jie Yuan, M.Sc. contact
Jinping Zhang, MD principal investigator
Shanghai 6th People's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Healthy Children, run by Min-Tze LIONG at 2 sites in 2 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Malaysia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Tze Liong, Ph.D. (6046532114, mintze.liong@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergy symptoms in children upon administration of probiotic or placebo as assessed via clinical questionnaire (time frame: Day-0, Day-180). 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 NCT07490587, 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 1 Apr 2026.