Crohn DiseaseNCT04965584
Microflora and Metabolomics of Crohn's Disease Patients
An observational study of Crohn Disease, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to explore the microflora characteristics of different ecological loci and multiple metabolic pathways in Crohn's disease patients with different disease course states. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Jul 2022
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Three different groups were created by healthy volunteers, patients with active Crohn's disease and patients with remission of Crohn's disease. The information of these individuals will be analyzed and some conclusions will be drawn.
Who may be able to join
- individuals who were clear and signed the informed consent.
- Male and female.
Who cannot join
- Any one who can not provide accurate information.
- Any one who denies the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
Kai Xia, MM, 13588251107, 987239945@qq.com
About this study
Official title: A Study Focused on the Microflora and Metabolomics of Crohn's Disease Patients
The purpose of this study is to explore the microflora characteristics of different ecological loci and multiple metabolic pathways in Crohn's disease patients with different disease course states.
Read the detailed description
This study aims to investigate the characteristics of microflora in the oral and tongue base, small intestinal stomy and lower respiratory tract, as well as the characteristics of multiple metabolic pathways such as bile acid metabolism and amino acid metabolism in Crohn's disease patients with different course states.
- Conditions
- Crohn Disease
- Keywords
- Crohn's disease, microbiota, metabonomics
- Medical subject headings
- Crohn Disease
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 |
|---|---|---|
| Active Crohn's disease group | Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited, and patients with CDAI score ≥ 150 were included in this group. | |
| Crohn's disease remission group | Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological features and histological features were recruited, and patients with CDAI score < 150 were included in this group. | |
| Healthy control group | Normal healthy people were randomly recruited as the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
The results were based on the 16S rRNA sequencing
Measured: 3 months
Small intestinal microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
The results were based on the 16S rRNA sequencing
Measured: 3 months
Sputum microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
The results were based on the 16S rRNA sequencing
Measured: 3 months
Secondary outcomes (1)
Metabolic difference of blood samples between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
The metabolites of the blood samples by LC-MS will be detected
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- 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
- NCT04965584
- Sponsor's protocol ID
- SHSYXK
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xia K, Gao R, Wu X, Sun J, Wan J, Wu T, Fichna J, Yin L, Chen C. Characterization of Specific Signatures of the Oral Cavity, Sputum, and Ileum Microbiota in Patients With Crohn's Disease. Front Cell Infect Microbiol. 2022 Apr 13;12:864944. doi: 10.3389/fcimb.2022.864944. eCollection 2022.
PubMed 35493739
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Focused on the Microflora and Metabolomics of Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT04965584
- Acronym / sponsor ID
- SHSYXK
- Conditions
- Crohn Disease
- Keywords
- Crohn's disease, microbiota, metabonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 16 Jul 2021 (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 purpose of this study is to explore the microflora characteristics of different ecological loci and multiple metabolic pathways in Crohn's disease patients with different disease course states.
Detailed description
This study aims to investigate the characteristics of microflora in the oral and tongue base, small intestinal stomy and lower respiratory tract, as well as the characteristics of multiple metabolic pathways such as bile acid metabolism and amino acid metabolism in Crohn's disease patients with different course states.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Crohn's disease group | – | –Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological manifestations and histological features were recruited, and patients with CDAI score ≥ 150 were included in this group. |
| Crohn's disease remission group | – | –Patients diagnosed with Crohn's disease after comprehensive evaluation of clinical symptoms, endoscopic features, radiological features and histological features were recruited, and patients with CDAI score < 150 were included in this group. |
| Healthy control group | – | –Normal healthy people were randomly recruited as the control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three different groups were created by healthy volunteers, patients with active Crohn's disease and patients with remission of Crohn's disease. The information of these individuals will be analyzed and some conclusions will be drawn.
Key inclusion criteria (2 listed)
- individuals who were clear and signed the informed consent.
- Male and female.
Key exclusion criteria (2 listed)
- Any one who can not provide accurate information.
- Any one who denies the study.
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
Oral microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
Time frame: 3 months
The results were based on the 16S rRNA sequencing
Small intestinal microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
Time frame: 3 months
The results were based on the 16S rRNA sequencing
Sputum microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
Time frame: 3 months
The results were based on the 16S rRNA sequencing
1 secondary outcome
Metabolic difference of blood samples between active stage of Crohn's disease, remission of Crohn's disease and healthy controls
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 35493739Xia K, Gao R, Wu X, Sun J, Wan J, Wu T, Fichna J, Yin L, Chen C. Characterization of Specific Signatures of the Oral Cavity, Sputum, and Ileum Microbiota in Patients With Crohn's Disease. Front Cell Infect Microbiol. 2022 Apr 13;12:864944. doi: 10.3389/fcimb.2022.864944. eCollection 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, 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 2 inclusion and 2 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 16 Jul 2021. 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?
Oral microbiota structure and function difference between active stage of Crohn's disease, remission of Crohn's disease and healthy controls (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965584, which also lists 1 linked publication.
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 16 Jul 2021.