Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

February 28, 2026 updated by: Wecare Probiotics Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 405200
        • Zhihui Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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;
  2. MP infection was confirmed in nasopharyngeal secretions and serum samples using PCR and ELISA;
  3. age between 6 months and 12 years;
  4. disease duration less than 2 weeks;
  5. written informed consent provided by the guardians.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics group
10B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.
Dietary supplement: Probiotic
The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, at discharge, d14).
Placebo Comparator: Placebo group
Dextrin, one strip/ day, before meals; Storage: Store in a cool, dry place without sun exposure.
Dietary supplement: Placebo
The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, at discharge, d14).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mycoplasma pneumoniae load
Time Frame: 7天
Mycoplasma pneumoniae load was detected by tNGS
7天

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

March 20, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WK2024004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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