Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

Mycoplasma Pneumoniae Pneumonia Clinical Trial

Official title:

Effect of Probiotic WecProB on the Course of Mycoplasma Pneumoniae Pneumonia in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348095
• Other study ID #: WK2024004
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 27, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Wecare Probiotics Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with mycoplasma pneumoniae 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 is diagnosed with Mycoplasma pneumoniae pneumonia using tNGS technology;

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.

Related Conditions & MeSH terms

• Mycoplasma Infections
• Mycoplasma Pneumoniae Pneumonia
• Pleuropneumonia
• Pneumonia
• Pneumonia, Mycoplasma

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	Mycoplasma pneumoniae load	Mycoplasma pneumoniae load was detected by tNGS	7?