Inflammatory Bowel DiseasesNCT05714566
Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients
An observational study of Inflammatory Bowel Diseases and Clostridium Difficile Infections, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of this research is to compare alterations of gut microbiota and fecal metabolomics alterations between inflammatory bowel disease patients infected with or without Clostridioides difficile. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Clostridium Difficile Infections, Microtia
- What is being tested?
- Clostridioides difficile toxin detection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2022to 30 Dec 2024
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 1. IBD group: inpatients diagnosed with ulcerative colitis or Crohn's disease. 2. IBD+CDI group: IBD patients positive for C.difficile toxin and having diarrhea 3. Health control: people without diarrhea or any other intestinal diseases and negative for C.difficile toxin tests
Who may be able to join
- inpatients diagnosed with ulcerative colitis or Crohn's disease in Renji hospital
- age from 18 to 75 years old
Who cannot join
- other infection caused diarrhea
- other metabolic diseases or inflammatory diseases
- patients who are not able to send back samples 4-6 weeks after therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai jiaotong university, school of medicine, affliated Renji hospital
Shanghai, Shanghai Municipality, 200127
Yang, 13262906006, 15828660135@163.com
Li, 13918363998, ruth_limin@126.com
About this study
Official title: Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations
The goal of this research is to compare alterations of gut microbiota and fecal metabolomics alterations between inflammatory bowel disease patients infected with or without Clostridioides difficile. The main questions it aim to answer are: which bacterial genus or fecal metabolites can discriminate IBD patients infected or more likely to be infected with Clostridioides difficile and their role in the pathogenesis of Clostridioides difficile.
type of study: observational study participant population/health conditions
- population diagnosed with Ulcerative colitis or Crohn's disease
- Having diarrhea Participants will be included in this research. If there is a comparison group: Researchers will compare healthy people without IBD or any diarrhea to see if disease or diarrhea would affect the gut microbiota and metabolites.
- Being tested
- Clostridioides difficile toxin detection
- Keywords
- Inflammatory bowel disease, Clostridium difficile disease
- Medical subject headings
- Inflammatory Bowel Diseases, Clostridium Infections, Congenital Microtia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridioides difficile toxin detectionDiagnostic test
Using Genexpert kit to detect the stool samples of IBD patients. If C. difficile toxin is positive, the patient is assigned to IBD+CDI group, or else assigned to IBD group. Every sample assigned to Health control group should have negative results for C.difficile toxin tests.
| Study group | Role | What they receive |
|---|---|---|
| IBD | Not described Receives: Diagnostic Test: Clostridioides difficile toxin detection | |
| IBD+CDI | Not described Receives: Diagnostic Test: Clostridioides difficile toxin detection | |
| Health control | Not described Receives: Diagnostic Test: Clostridioides difficile toxin detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
C.difficile positive
C.difficile toxin test is positive
Measured: 1 day
C.difficile negative
C.difficile toxin test is negative
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start7 Nov 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Li, professor, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714566
- Sponsor's protocol ID
- LY2022-059-B
- Status last verified
- Nov 2023
- First submitted
- 27 Jan 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: gut microbiota and metabolites change
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Biomarkers of Clostridioides Difficile Infection in Inflammatory Bowel Disease Patients Defined by Gut Microbiome and Fecal Metabolomics Alterations
- ClinicalTrials.gov ID
- NCT05714566
- Acronym / sponsor ID
- LY2022-059-B
- Keywords
- Inflammatory bowel disease, Clostridium difficile disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 6 Feb 2023 (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.
The goal of this research is to compare alterations of gut microbiota and fecal metabolomics alterations between inflammatory bowel disease patients infected with or without Clostridioides difficile. The main questions it aim to answer are: which bacterial genus or fecal metabolites can discriminate IBD patients infected or more likely to be infected with Clostridioides difficile and their role in the pathogenesis of Clostridioides difficile.
type of study: observational study participant population/health conditions
- population diagnosed with Ulcerative colitis or Crohn's disease
- Having diarrhea Participants will be included in this research. If there is a comparison group: Researchers will compare healthy people without IBD or any diarrhea to see if disease or diarrhea would affect the gut microbiota and metabolites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD | – | Diagnostic Test: Clostridioides difficile toxin detection |
| IBD+CDI | – | Diagnostic Test: Clostridioides difficile toxin detection |
| Health control | – | Diagnostic Test: Clostridioides difficile toxin detection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. IBD group: inpatients diagnosed with ulcerative colitis or Crohn's disease. 2. IBD+CDI group: IBD patients positive for C.difficile toxin and having diarrhea 3. Health control: people without diarrhea or any other intestinal diseases and negative for C.difficile toxin tests
Key inclusion criteria (2 listed)
- inpatients diagnosed with ulcerative colitis or Crohn's disease in Renji hospital
- age from 18 to 75 years old
Key exclusion criteria (3 listed)
- other infection caused diarrhea
- other metabolic diseases or inflammatory diseases
- patients who are not able to send back samples 4-6 weeks after therapy
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 |
|---|---|---|
| Clostridioides difficile toxin detectionUsing Genexpert kit to detect the stool samples of IBD patients. If C. difficile toxin is positive, the patient is assigned to IBD+CDI group, or else assigned to IBD group. Every sample assigned to Health control group should have negative results for C.difficile toxin tests. | Diagnostic test | Health control, IBD, IBD+CDI |
Primary outcome
C.difficile positive
Time frame: 1 day
C.difficile toxin test is positive
C.difficile negative
Time frame: 1 day
C.difficile toxin test is negative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided. gut microbiota and metabolites change
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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. This study is not recruiting at the moment.
Min Li, professor principal investigator
Shanghai Jiao Tong University School of Medicine
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 Inflammatory Bowel Diseases and Clostridium Difficile Infections, run by RenJi Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang (13262906006, 15828660135@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C.difficile positive (time frame: 1 day). The study lists 2 primary outcomes in all. 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 18 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.