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A multicenter, prospective, randomized controlled study on the intervention of Saccharomyces boulardii for recurrent respiratory tract infections

A multicenter, prospective, randomized controlled study on the intervention of Saccharomyces boulardii for recurrent respiratory tract infections

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105675
Enrollment
Unknown
Registered
2025-07-09
Start date
2025-07-09
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Recurrent respiratory tract infections

Interventions

Control group:The control group did not use Saccharomyces boulardii and only received conventional treatment.
Intervention Group:The intervention group took Saccharomyces boulardii

Sponsors

Children's Hospital,Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 2-7 years (greater than 2 years old, less than or equal to 7 years old); 2.Meet the criteria for recurrent respiratory tract infection, see (Chinese Medical Association Pediatrics Branch Respiratory Group. Chinese Journal of Pediatrics. 2008, 46(2): 108-110); 3.Sign the informed consent form and be willing to cooperate in follow-up and biological sample collection;

Exclusion criteria

Exclusion criteria: 1.Patients with clearly diagnosed primary or secondary immunodeficiency; 2.Patients with combined malformation or severe chronic systemic diseases (such as congenital heart disease, chronic renal insufficiency, pulmonary dysplasia, etc.); 3.Patients with diseases that require hormones, antibiotics, etc. (including but not limited to asthma, bacterial infections, etc.); 4.Combined respiratory foreign body; 5.Receiving immunopotentiators or probiotics or using antibiotics within 4 weeks before the study; 6.Those with a history of allergy to Saccharomyces boulardii preparations; 7.Family members cannot guarantee compliance or cannot complete follow-up;

Design outcomes

Primary

MeasureTime frame
Number of antibiotics used;PedsQL quality of life score;Annual number of respiratory infections;

Secondary

MeasureTime frame
Adverse event rates and serious adverse events (SAEs);Differential expression of immune pathway genes;Changes in lipid metabolism profile;Changes in immune-related factors;Diversity and structural changes of intestinal flora;score of Gastrointestinal Symptom Rating Scale;

Countries

China

Contacts

Public ContactYan Li

Children's Hospital,Zhejiang University School of Medicine

liyan0079@zju.edu.cn+86 157 1570 8966

Outcome results

None listed

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