A Phase 2 interventional study of Probiotic and Placebo in Healthy Children, sponsored by Min-Tze LIONG. Recruiting at 2 sites in 2 countries. Open to participants aged 0 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Min-Tze LIONG · Phase 2, Interventional, and Prevention
Among 33 studies in Hypersensitivity with a site in China — 8 open to participants now, 8 under way, none of them phase 3. Hypersensitivity · China.
Among the 33 studies in Hypersensitivity with a site in China, this one is the 5th largest by planned enrollment of the 18 interventional ones, is one of 2 that started in 2024, is one of 2 in phase 2, and was the 31st registered.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 366 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →8 of the 33 studies in Hypersensitivity with a site in China are open now, in 3 countries. Each count lists the studies.
Of the 100 Hypersensitivity studies recruiting now, 37 (37%) set no upper age limit and 51 (51%) stop at 75 or younger; 55 take children under 18; 36 take healthy volunteers.
This study: 0 Months to 36 Months · all sexes · healthy volunteers too.
The full table on the hub →33 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2024.
Median enrollment 169 across the 18 interventional studies, 180 across the 15 observational. Of the 18 that completed or were terminated, 1 (6%) have results posted.
10 of 33 have an industry lead sponsor. The 10 most frequent:
Min-Tze LIONG is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
Min-Tze LIONG has 1 study filed under Hypersensitivity — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 33 studies in Hypersensitivity with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient
Dietary Supplement: Probiotic
One sachet daily (2 g) containing only maltodextrin as excipient
Dietary Supplement: Placebo
One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient
One sachet daily (2g) containing only maltodextrin as excipient
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.
Time frame: Day-0, Day-180
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
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)
Differences in gut immune biomarkers in fecal sample of children upon administration of probiotic or placebo, such as secretory immunoglobulin A (sIgA).
Time frame: 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.
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
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).
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.
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.
Time frame: Day-0, Day-180
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Jun 2026, 29 months after the start.
Of 30 phase 2 interventional studies under Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 51. This study's planned 29 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Probiotic
Min-Tze LIONG