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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06348095
Other study ID # WK2024004
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 7, 2024
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Wecare Probiotics Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with viral pneumonia, in comparison with placebo.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date December 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 3 Years
Eligibility Inclusion Criteria: 1. Meet the diagnostic criteria for pneumonia in "Zhufutang Practical Pediatrics" (7th Edition), and the rapid test of nasopharyngeal secretions is positive for RSV, and the diagnosis is confirmed as RSVP; 2. Infants and young children aged 6 months to 3 years; 3. The course of the disease is <48 h; 4. The family members of the children are informed about the study and sign the informed consent form. Exclusion Criteria: 1. Previous history of wheezing; 2. Cardiovascular disease and congenital tracheal dysplasia; 3. pneumonia induced by other causes; 4. Dysplasia of bronchial and pulmonary tracts; 5. premature infants; 6. Combined with immunosuppressive diseases; 7. Presence of mental illness.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic
The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, d3, d7, d14).
Placebo
The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, d3, d7, d14).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wecare Probiotics Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory syncytial virus (RSV) viral load Viral load was detected by real-time quantitative RT-PCR 7 days
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