Crohn DiseaseNCT05615116
Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease
An observational study of Crohn Disease and Microtia, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
In this study, the microbiota sequencing was used to investigate the changes of microbiota in the terminal ileum and the middle part of ascending colon, the mesenteric adipose tissue of ileum and ascending mesocolon, and oral cavity of patients with Crohn's disease before and after ileocecal resection, so as to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease, Microtia, Ileocecal; Lesion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2022to 15 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Crohn's patients before and after ileocecal resection were divided into two groups， the information of these individuals will be analyzed and some conclusions will be drawn.
Who may be able to join
- Clinical diagnosis of Crohn's disease
Who cannot join
- Serious oral diseases (e.g. dental caries, periodontal disease) Other acute or chronic gastrointestinal diseases Probiotics or prebiotic consumption and antibiotic use within 1 month
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
In this study, the microbiota sequencing was used to investigate the changes of microbiota in the terminal ileum and the middle part of ascending colon, the mesenteric adipose tissue of ileum and ascending mesocolon, and oral cavity of patients with Crohn's disease before and after ileocecal resection, so as to further explore the role of ileocecal region in inducing remission of disease.
- Conditions
- Crohn Disease, Microtia, Ileocecal; Lesion
- Medical subject headings
- Crohn Disease, Congenital Microtia
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 |
|---|---|---|
| Before ileocecal resection | Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited，and the patients were admitted for right hemicolectomy | |
| After ileocecal resection | Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited，and the patients underwent reversal of ileostoma after right hemicolectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial changes of intestinal mucosa
Explore the microbial changes in the mucosa of the terminal ileum and the middle segment of the ascending colon in patients with Crohn's disease before and after ileocecal resection through metagenomic analysis
Measured: 6 month
Secondary outcomes (1)
Microbial changes of mesenteric adipose tissue
Explore the microbial changes in the mesenteric adipose tissue of the terminal ileum and the middle segment of the ascending colon in patients with Crohn's disease before and after ileocecal resection through metagenomic analysis
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Nov 2022 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615116
- Sponsor's protocol ID
- xkkb-2022
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Distribution of Digestive Tract Microbiota Before and After Ileocecal Resection in Crohn's Disease
- ClinicalTrials.gov ID
- NCT05615116
- Acronym / sponsor ID
- xkkb-2022
- Conditions
- Crohn Disease, Microtia, Ileocecal; Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 14 Nov 2022 (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.
In this study, the microbiota sequencing was used to investigate the changes of microbiota in the terminal ileum and the middle part of ascending colon, the mesenteric adipose tissue of ileum and ascending mesocolon, and oral cavity of patients with Crohn's disease before and after ileocecal resection, so as to further explore the role of ileocecal region in inducing remission of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before ileocecal resection | – | –Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited，and the patients were admitted for right hemicolectomy |
| After ileocecal resection | – | –Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited，and the patients underwent reversal of ileostoma after right hemicolectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Crohn's patients before and after ileocecal resection were divided into two groups， the information of these individuals will be analyzed and some conclusions will be drawn.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Crohn's disease
Key exclusion criteria (1 listed)
- Serious oral diseases (e.g. dental caries, periodontal disease) Other acute or chronic gastrointestinal diseases Probiotics or prebiotic consumption and antibiotic use within 1 month
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
Microbial changes of intestinal mucosa
Time frame: 6 month
Explore the microbial changes in the mucosa of the terminal ileum and the middle segment of the ascending colon in patients with Crohn's disease before and after ileocecal resection through metagenomic analysis
1 secondary outcome
Microbial changes of mesenteric adipose tissue
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Crohn Disease and Microtia, run by Shanghai 10th People's 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 1 inclusion and 1 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 14 Nov 2022. 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 Kai Xia, MM (13588251107, 987239945@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial changes of intestinal mucosa (time frame: 6 month). 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 14 Nov 2022.