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To investigate the effects of Bifidobacterium animalis subsp. lactis XLTG11 on growth and development, incidence of allergy and immune function in infants

To investigate the effects of Bifidobacterium animalis subsp. lactis XLTG11 on growth and development, incidence of allergy and immune function in infants

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080559
Enrollment
Unknown
Registered
2024-02-01
Start date
2023-10-23
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy-related diseases

Interventions

Control group:Oral placebo
Breastfeeding control group:None

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: (1) Term infants are 37= gestational age < 42 weeks, and the birth weight is between 2500g and 4000g (only applicable to 0~12 months old); (2) Breastfed or mixed-fed healthy infants and young children, aged 0~3 (inclusive) years old, gender is not limited; (3)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). (4) Family primary guardians agree to collect fecal samples of infants and young children during this study; (5) Have not used antibiotics in the past month (6) Have not used probiotics in the past three months (7) Family primary guardians committed not to add additional Bifidobacterium dietary supplements to infants and young children during the intervention period; (8) 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; (9) Signed informed consent and willing to follow up at the time specified in the trial

Exclusion criteria

Exclusion criteria: (1) The mother of the infant has a history of diabetes, hepatitis B, HIV and other infectious diseases; (2) 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; (3) Infants and young children who are known to be allergic to the ingredients of probiotic products; (4) In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study

Design outcomes

Primary

MeasureTime frame
Incidence of allergies;

Secondary

MeasureTime frame
Intestinal flora;Calprotectin;secretory immunoglobulin A;human ß-defensin 2 ;Antimicrobial Peptide LL-37;height;weight;Head circumference;Defecation situation;Incidence of non-allergic disease;

Countries

China

Contacts

Public ContactZhang Jinping

Shanghai Sixth People's Hospital

zhang-jin-ping@163.com+86 180 1757 9729

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026