Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

NCT06348095 | Completed

• 1 other identifier: WK2024004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mycoplasma Pneumoniae Pneumonia

Outcome Measures

Primary Outcomes (1)

• Mycoplasma pneumoniae load

  Mycoplasma pneumoniae load was detected by tNGS

  7天

Study Arms (2)

Probiotics group

EXPERIMENTAL

10B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotics group

Placebo DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Zhihui Liu

Chongqing, Chongqing Municipality, 405200, China

Location

MeSH Terms

Conditions

Pneumonia, Mycoplasma

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: June 1, 2024
• Primary Completion: March 20, 2025
• Study Completion: August 31, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (1)