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Bifidobacterium longum BB536 for Establishing a core dominant Bifidobacterium microbiota and preventing allergies in infants and young children born by cesarean section: A multicenter, randomized, double-blind controlled study

Bifidobacterium longum BB536 for Establishing a core dominant Bifidobacterium microbiota and preventing allergies in infants and young children born by cesarean section: A multicenter, randomized, double-blind controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110512
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-10-30
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Allergic diseases

Interventions

Intervention group:Once a day, 6 drops each time (Bifidobacterium longum subsp. longum BB536, 1×10^9 CFU/day). The treatment course starts on the day of randomization, with continuous probiotic supple
Control group:No probiotics are used
At the same time, a placebo (containing only maltodextrin, with the same appearance and taste as the probiotic preparation but without any probiotic components) was given, using the same method as the

Sponsors

Chengdu Women and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Term cesarean-section (CS)-born infants (gestational age: >=37 weeks and =6 points on the Infant Allergy Risk Assessment Form (referenced from the Maternal and Child Health Center of Chinese Center for Disease Control and Prevention: Survey on Infant Allergy Symptoms and Risk Factors);? 5. Legal guardians of the infant agree to provide the infant’s fecal samples during the study;? 6. Legal guardians of the infant agree to participate in the study, sign the informed consent form, and comply with the required follow-up plan and complete the necessary follow-up forms.

Exclusion criteria

Exclusion criteria: 1. Mothers with severe diseases during pregnancy, including liver dysfunction, renal insufficiency, cardiovascular diseases, respiratory disorders, endocrine/metabolic disorders, or infectious diseases (e.g., hepatitis B, AIDS);? 2. Mothers with regular probiotic supplementation (=5 days/week) within 3 months before delivery;? 3. Infants who used antibiotics, hormones, or immunosuppressants before enrollment;? 4. Infants with severe congenital diseases/malformations, immune deficiency, major organ dysfunction, hereditary/metabolic diseases, or digestive tract/other infectious diseases;? 5. Infants with confirmed intolerance to other components of the study probiotic preparation;? 6. Infants or their mothers who participated in or are participating in clinical trials within the past 3 months;? 7. Infants deemed unsuitable for the study by researchers for other reasons;? 8. Infants from multiple pregnancies.

Design outcomes

Primary

MeasureTime frame
Gut microbiota analysis;Allergic diseases incidence;

Countries

China

Contacts

Public ContactChen Ke

Chengdu Women and Children's Central Hospital

263662086@qq.com+86 139 8178 2973

Outcome results

None listed

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