Clostridioides Difficile InfectionNCT06788769
Study of Clostridioides Difficile in Infants
An observational study of Clostridioides Difficile Infection, run by Westlake University at 1 site in China.
Trial summary
Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually. This retrospective study aims to explore the epidemiological characteristics, clinical manifestations, and potential biomarkers of CDI in children aged 0-2 years by examining… Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Clostridioides Difficile Infection
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: This retrospective observational study will include infants aged 0 to 2 years who underwent clinical evaluation and stool testing for Clostridioides difficile at [Hospital(s)/Institution(s)/Region]. The study population is divided into three groups: 1. CDI Patients: Infants with laboratory-confirmed C. difficile (PCR or culture) and clinical symptoms consistent with infection (e.g., diarrhea, abdominal pain). 2. Asymptomatic Carriers: Infants who tested positive for C. difficile but did not exhibit any related symptoms. 3. Healthy Controls: Infants who tested negative for C. difficile and had no history of gastrointestinal symptoms during the same period. All participants included in this analysis will have relevant medical records and stool sample data available within the study's retrospective timeframe. Additional questionnaire data may be collected from parents or guardians to assess potential risk factors and environmental exposures
Who may be able to join
- Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation.
- Data Availability: Complete medical records or available stool samples within the study's retrospective time frame.
- Group-Specific Criteria:
- CDI Patients: Documented diarrhea or related gastrointestinal symptoms, with laboratory-confirmed C. difficile by PCR or culture.
- Asymptomatic Carriers: Positive C. difficile test (PCR or culture) in the absence of diarrhea or other clinical CDI symptoms.
- Healthy Controls: Negative C. difficile test and no gastrointestinal symptoms indicative of CDI.
- Consent/Authorization:Retrospective data (e.g., existing medical records or stored biosamples) may be included under a waiver of consent if approved by the institutional review board (IRB). However, any new information obtained directly from participants or their guardians (e.g., via questionnaires) requires explicit informed consent.
Who cannot join
- Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results.
- Ambiguous Diagnosis: Patients presenting with other infectious diseases or conditions that could not rule out alternative diagnoses for diarrhea (e.g., confirmed concurrent viral or parasitic infections) without conclusive C. difficile testing.
- Severe Comorbidities: Infants with life-threatening congenital conditions (e.g., severe immunodeficiency syndromes) if these conditions significantly alter the gut microbiota or confound CDI diagnosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000
Liqian Wang, 86-18768156110, wanglq921206@163.com
About this study
Official title: Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection
Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually. This retrospective study aims to explore the epidemiological characteristics, clinical manifestations, and potential biomarkers of CDI in children aged 0-2 years by examining three cohorts: (1) infants diagnosed with CDI, (2) asymptomatic carriers of C. difficile, and (3) healthy controls. Fecal samples from each group will undergo metagenomic sequencing and metabolomic profiling, coupled with questionnaire-based surveys for risk factor assessment. The findings are anticipated to identify key high-risk factors, elucidate the pathogenic mechanisms underlying infant CDI, and support the development of early diagnostic tools and preventive strategies.
- Conditions
- Clostridioides Difficile Infection
- Keywords
- Clostridioides Difficile, Infants
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CDI Patients | This group includes infants aged 0-2 years who have been diagnosed with Clostridioides difficile infection (CDI). Diagnosis is based on clinical symptoms such as diarrhea, abdominal pain, or fever, along with positive laboratory confirmation (e.g., stool PCR or culture for C. difficile). | |
| Asymptomatic Clostridioides difficile Carriers | This group includes infants aged 0-2 years who are colonized with Clostridioides difficile but show no clinical symptoms of infection. Participants in this group tested positive for C. difficile in fecal samples collected during routine or study-related screening. | |
| Healthy Infants | This group includes infants aged 0-2 years who do not show any clinical symptoms of infection and have tested negative for Clostridioides difficile in fecal samples. Participants were recruited from general pediatric clinics or community health programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Clostridioides difficile infection (CDI) and asymptomatic carriage in infants
The prevalence of CDI and asymptomatic C. difficile carriage will be determined by testing fecal samples for C. difficile using PCR and/or culture methods. Participants are categorized into three groups based on clinical symptoms (diarrhea, abdominal pain, or fever) and laboratory confirmation (positive PCR or stool culture).
Specifically, the primary outcome assesses:
- The proportion of infants (0-2 years) testing positive for C. difficile who exhibit clinical symptoms (CDI patients).
- The proportion of infants (0-2 years) testing positive but showing no symptoms (asymptomatic carriers), and the proportion of infants testing negative (healthy controls).
Measured: Data from medical records and stool sample tests collected retrospectively between July 2024 and December 2026.
Secondary outcomes (1)
Gut Microbial Diversity Among CDI Patients, Asymptomatic Carriers, and Healthy Controls
Metagenomic sequencing will be performed on fecal samples to assess alpha and beta diversity.The goal is to compare microbial community shifts and identify specific taxa changes associated with CDI.
Measured: Same retrospective collection period (2024-2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start1 Jul 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788769
- Sponsor's protocol ID
- 20241202TL001
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Risk Factors and Microbiome Alterations in Infant Clostridioides Difficile Infection
- ClinicalTrials.gov ID
- NCT06788769
- Acronym / sponsor ID
- 20241202TL001
- Conditions
- Clostridioides Difficile Infection
- Keywords
- Clostridioides Difficile, Infants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Jan 2025 (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.
Clostridioides difficile infection (CDI) poses an increasing threat to infant and young child health, with detection rates rising annually. This retrospective study aims to explore the epidemiological characteristics, clinical manifestations, and potential biomarkers of CDI in children aged 0-2 years by examining three cohorts: (1) infants diagnosed with CDI, (2) asymptomatic carriers of C. difficile, and (3) healthy controls. Fecal samples from each group will undergo metagenomic sequencing and metabolomic profiling, coupled with questionnaire-based surveys for risk factor assessment. The findings are anticipated to identify key high-risk factors, elucidate the pathogenic mechanisms underlying infant CDI, and support the development of early diagnostic tools and preventive strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CDI Patients | – | –This group includes infants aged 0-2 years who have been diagnosed with Clostridioides difficile infection (CDI). Diagnosis is based on clinical symptoms such as diarrhea, abdominal pain, or fever, along with positive laboratory confirmation (e.g., stool PCR or culture for C. difficile). |
| Asymptomatic Clostridioides difficile Carriers | – | –This group includes infants aged 0-2 years who are colonized with Clostridioides difficile but show no clinical symptoms of infection. Participants in this group tested positive for C. difficile in fecal samples collected during routine or study-related screening. |
| Healthy Infants | – | –This group includes infants aged 0-2 years who do not show any clinical symptoms of infection and have tested negative for Clostridioides difficile in fecal samples. Participants were recruited from general pediatric clinics or community health programs. |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This retrospective observational study will include infants aged 0 to 2 years who underwent clinical evaluation and stool testing for Clostridioides difficile at [Hospital(s)/Institution(s)/Region]. The study population is divided into three groups: 1. CDI Patients: Infants with laboratory-confirmed C. difficile (PCR or culture) and clinical symptoms consistent with infection (e.g., diarrhea, abdominal pain). 2. Asymptomatic Carriers: Infants who tested positive for C. difficile but did not exhibit any related symptoms. 3. Healthy Controls: Infants who tested negative for C. difficile and had no history of gastrointestinal symptoms during the same period. All participants included in this analysis will have relevant medical records and stool sample data available within the study's retrospective timeframe. Additional questionnaire data may be collected from parents or guardians to assess potential risk factors and environmental exposures
Key inclusion criteria (7 listed)
- Age Range: Infants aged 0 to 2 years (inclusive) at the time of sample collection or medical record documentation.
- Data Availability: Complete medical records or available stool samples within the study's retrospective time frame.
- Group-Specific Criteria:
- CDI Patients: Documented diarrhea or related gastrointestinal symptoms, with laboratory-confirmed C. difficile by PCR or culture.
- Asymptomatic Carriers: Positive C. difficile test (PCR or culture) in the absence of diarrhea or other clinical CDI symptoms.
Key exclusion criteria (3 listed)
- Incomplete Data: Infants whose medical records lack sufficient information to confirm their CDI status or those without adequate stool sample results.
- Ambiguous Diagnosis: Patients presenting with other infectious diseases or conditions that could not rule out alternative diagnoses for diarrhea (e.g., confirmed concurrent viral or parasitic infections) without conclusive C. difficile testing.
- Severe Comorbidities: Infants with life-threatening congenital conditions (e.g., severe immunodeficiency syndromes) if these conditions significantly alter the gut microbiota or confound CDI diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Clostridioides difficile infection (CDI) and asymptomatic carriage in infants
Time frame: Data from medical records and stool sample tests collected retrospectively between July 2024 and December 2026.
The prevalence of CDI and asymptomatic C. difficile carriage will be determined by testing fecal samples for C. difficile using PCR and/or culture methods. Participants are categorized into three groups based on clinical symptoms (diarrhea, abdominal pain, or fever) and laboratory confirmation (positive PCR or stool culture). Specifically, the primary outcome assesses: 1. The proportion of infants (0-2 years) testing positive for C. difficile who exhibit clinical symptoms (CDI patients). 2. The proportion of infants (0-2 years) testing positive but showing no symptoms (asymptomatic carriers), and the proportion of infants testing negative (healthy controls).
1 secondary outcome
Gut Microbial Diversity Among CDI Patients, Asymptomatic Carriers, and Healthy Controls
Time frame: Same retrospective collection period (2024-2026)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridioides Difficile Infection, run by Westlake University 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Tao, PHD (86-19817412816, taoliang@westlake.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Clostridioides difficile infection (CDI) and asymptomatic carriage in infants (time frame: Data from medical records and stool sample tests collected retrospectively between July 2024 and December 2026.). 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 23 Jan 2025.