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Completed

NCT Number: NCT06348095

Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

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.

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Key information

Conditions

Mycoplasma Pneumoniae Pneumonia Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Lung Diseases Mycoplasma Infections Mycoplasmatales Infections Pneumonia Pneumonia, Bacterial Pneumonia, Mycoplasma Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhihui Liu

Chongqing, Chongqing Municipality, 405200, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of MPP based on typical clinical manifestations (e.g., fever, cough, abnormal pulmonary auscultation), radiographic evidence of pneumonia on chest imaging, and laboratory findings in accordance with current pediatric community-acquired pneumonia guidelines;
  • MP infection was confirmed in nasopharyngeal secretions and serum samples using PCR and ELISA;
  • age between 6 months and 12 years;
  • disease duration less than 2 weeks;
  • written informed consent provided by the guardians.

Exclusion criteria

  • Previous history of wheezing;
  • Cardiovascular disease and congenital tracheal dysplasia;
  • pneumonia induced by other causes;
  • Dysplasia of bronchial and pulmonary tracts;
  • premature infants;
  • Combined with immunosuppressive diseases;
  • Presence of mental illness.

Treatment and study plan

Probiotic

Dietary Supplement

The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, at discharge, d14).

Placebo

Dietary Supplement

The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, at discharge, d14).

Primary outcomes

  1. Mycoplasma pneumoniae load

    Time frame: 7天

    Mycoplasma pneumoniae load was detected by tNGS

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2024
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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