Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

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: Mycoplasma Pneumoniae Pneumonia
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Mycoplasma pneumoniae load was detected by tNGS	7天

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

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: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Pneumonia, Bacterial; Mycoplasmatales Infections; Mycoplasma Infections; Pneumonia, Mycoplasma; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• 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