Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

Not Applicable

Not yet recruiting

• Conditions: Mycoplasma Pneumoniae Pneumonia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT06348095
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-04
• Status Verified: 2024-05
• Study Start: 2024-05-27
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Maltodextrin, one strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.
Probiotics group	Probiotic	2B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.

Primary Outcome Measures

Name	Time	Method
Mycoplasma pneumoniae load	7天	Mycoplasma pneumoniae load was detected by tNGS