To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants

NCT07490587 | Recruiting Phase 2

• 1 other identifier: 2023-142
• Study Type: interventional
• Target: 366
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Healthy Children

Keywords

children; probiotic; allergy; bifidobacterium

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  Day-0, Day-180

• Defecation frequency in children upon administration of probiotic or placebo as assessed via daily stool diary

  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

  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.

  Day-0, Day-180

Study Arms (2)

Probiotic

EXPERIMENTAL

One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

One sachet daily (2 g) containing only maltodextrin as excipient

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient

Probiotic

Placebo DIETARY_SUPPLEMENT

One sachet daily (2g) containing only maltodextrin as excipient

Placebo

Eligibility Criteria

• Age: 0 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Min-Tze LIONG: lead
• Shanghai 6th People's Hospital: collaborator

Study Sites (2)

Shanghai Sixth People's Hospital

Pudong, Shanghai Municipality, 201306, China

RECRUITING

Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, 11800, Malaysia

NOT YET RECRUITING

MeSH Terms

Conditions

Hypersensitivity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jinping Zhang, MD

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Tze Liong, Ph.D.

CONTACT

6046532114; mintze.liong@usm.my

Jie Yuan, M.Sc.

CONTACT

peanut.yuan@diprobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); MY (1)