Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

Wecare Probiotics

Status: Not yet enrolling

Conditions: Mycoplasma Pneumoniae Pneumonia

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06348095

WK2024004

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups, including a placebo group

Probiotics group

Experimental group

Description:

2B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

Maltodextrin, one strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.

Treatment:

Dietary Supplement: Placebo