Mycoplasma Pneumoniae PneumoniaNCT06348095
Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia
A study testing Probiotic in people with Mycoplasma Pneumoniae Pneumonia, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Mycoplasma Pneumoniae Pneumonia
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mycoplasma Pneumoniae Pneumonia
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Pneumonia, Mycoplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, at discharge, d14).
PlaceboDietary supplement
The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, at discharge, d14).
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | 10B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure. Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Dextrin, one strip/ day, before meals; Storage: Store in a cool, dry place without sun exposure. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycoplasma pneumoniae load
Mycoplasma pneumoniae load was detected by tNGS
Measured: 7天
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jun 2024
- Primary completion20 Mar 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycoplasma Pneumoniae PneumoniaStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348095
- Sponsor's protocol ID
- WK2024004
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic WecProB on the Course of Mycoplasma Pneumoniae Pneumonia in Children
- ClinicalTrials.gov ID
- NCT06348095
- Acronym / sponsor ID
- WK2024004
- Conditions
- Mycoplasma Pneumoniae Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Experimental | Dietary Supplement: Probiotic10B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboDextrin, one strip/ day, before meals; Storage: Store in a cool, dry place without sun exposure. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Previous history of wheezing;
- Cardiovascular disease and congenital tracheal dysplasia;
- pneumonia induced by other causes;
- Dysplasia of bronchial and pulmonary tracts;
- premature infants;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticThe experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, at discharge, d14). | Dietary supplement | Probiotics group |
| PlaceboThe experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, at discharge, d14). | Dietary supplement | Placebo group |
Primary outcome
Mycoplasma pneumoniae load
Time frame: 7天
Mycoplasma pneumoniae load was detected by tNGS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Mycoplasma Pneumoniae Pneumonia, run by Wecare Probiotics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycoplasma pneumoniae load (time frame: 7天). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.