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Clinical effect and intestinal microecology of bifidobacteria intervention in early life of infants with high risk of allergy

Clinical effect and intestinal microecology of bifidobacteria intervention in early life of infants with high risk of allergy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078326
Enrollment
Unknown
Registered
2023-12-05
Start date
2019-06-04
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Allergic disease

Interventions

Healthy control group:No special intervention
Blank control group with high risk of allergy:No special intervention
High-risk probiotic intervention group:1*10^9 colony-forming units of M-1V probiotics were administered daily

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Newborns at hiah risk of allera. family history of atopic disease. defned as one or more family members (mother. father. or older siblinas) withallergic eczema allergic rhinitis. or asthma.Healthy controls were defined as those without family history of atopic diseases

Exclusion criteria

Exclusion criteria: 1,Severe henatic dusfunction.renal dysfunction. cardiovascula disease. respiratory dysfunction.endocrine disorder, or metabolic dysfunctioduring pregnancy. She had a history of antibiotic use within 1 month before delivery 2, Premature or post-term birth,severe pulmonary dysplasia, conenital heart disease. diaestive tract malformation and other birth defectshistony of birth asphyxia, neonatal use of antibiotics. 3,Habitual intake of probiotic supplements during pregnancy or plan to give other probiotic or prebiotic supplements to intants 4, Mothers who have participated in other clinical trials within 8 weeks or are participating in other drug clinical trials 5,According to the researchers' judgment, other diseases or conditions that may reduce or complicate enrollment, such as unstable living environment and inconvenient transportation, are likely to cause loss of follow-up.

Design outcomes

Primary

MeasureTime frame
Atopic dermatitis SCORAD score;

Secondary

MeasureTime frame
Allergy-related symptom Score (CoMisS);Fecal calprotectin;flora analysis;Metabolite analysis;

Countries

China

Contacts

Public ContactYi YU

Ruijin Hospital, Shanghai Jiao Tong UniversitySchool of Medicine

yuyi413@126.com+86 156 1893 0102

Outcome results

None listed

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