Inflammatory Bowel DiseasesNCT06447870
Research on the Mechanisms of Treatment Non-response in Inflammatory Bowel Disease Based on Multi-omics Technology
An observational study of Inflammatory Bowel Diseases, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
In recent years, biologic agents such as infliximab, vedolizumab, and ustekinumab have demonstrated tremendous potential in the treatment of inflammatory bowel disease (IBD), altering the traditional treatment paradigm for IBD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- biologic therapy(eg:IFX,ADA,UST,VDZ)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: based on the treating physician's judgment, The patients require biologic therapy with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) after 3 months of medication. Patients were then divided into two groups based on whether primary non-response occurred or not.
Who may be able to join
- Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) after 3 months of medication.
Who cannot join
- Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanFang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Xinmei Zhao, Applicant, 13268270713, xmzhao914@163.com
About this study
In recent years, biologic agents such as infliximab, vedolizumab, and ustekinumab have demonstrated tremendous potential in the treatment of inflammatory bowel disease (IBD), altering the traditional treatment paradigm for IBD. Despite their significant efficacy, there remains a subset of patients who do not respond to biologic agents, necessitating research into the response mechanisms of biologic therapy to explore more precise treatment strategies. Preliminary work by the principal investigator has identified multiple potential responder cell subtypes to biologic agents, which may be influenced by the gut and oral microbiota. Therefore, this project proposes to investigate the mechanisms of response to biologic agents, aiming to explore more precise treatment strategies, through the integration of single-cell transcriptomics, 16S rRNA, and other multi-omics technologies on tissue samples, feces, saliva, peripheral blood, etc., from IBD patients before and after treatment. This will involve integrating bioinformatics analysis and in vitro/in vivo functional validation to elucidate the roles of treatment-responsive cell subtypes and gut and oral microbiota in the inflammatory microenvironment of the intestine, with the aim of uncovering the mechanisms of biologic agent therapy and providing new clues for the development of next-generation drug targets.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- biologic therapy(eg:IFX,ADA,UST,VDZ)
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic therapy(eg:IFX,ADA,UST,VDZ)Drug
The patients received biologic therapy during the baseline period, and the specific type of medication was determined based on the professional doctor's diagnosis and treatment opinions. Patients were then divided into two groups based on whether primary non-response occurred or not.
| Study group | Role | What they receive |
|---|---|---|
| primary non-response group | biologic therapy(eg:IFX,ADA,UST,VDZ) Receives: Drug: biologic therapy(eg:IFX,ADA,UST,VDZ) | |
| response group | biologic therapy(eg:IFX,ADA,UST,VDZ) Receives: Drug: biologic therapy(eg:IFX,ADA,UST,VDZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response rate
The ratio of patients achieving clinical response to the total number of treated patients.
Measured: 3 months after biologic therapy began
clinical remission rate
The ratio of patients achieving clinical remission to the total number of treated patients.
Measured: 3 months after biologic therapy began
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Dec 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (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.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447870
- Sponsor's protocol ID
- NFEC-2024-128
- Status last verified
- Jun 2024
- First submitted
- 19 May 2024
- Last updated
- 7 Jun 2024
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Mechanisms of Treatment Non-response in Inflammatory Bowel Disease Based on Multi-omics Technology
- ClinicalTrials.gov ID
- NCT06447870
- Acronym / sponsor ID
- NFEC-2024-128
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Jun 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.
In recent years, biologic agents such as infliximab, vedolizumab, and ustekinumab have demonstrated tremendous potential in the treatment of inflammatory bowel disease (IBD), altering the traditional treatment paradigm for IBD. Despite their significant efficacy, there remains a subset of patients who do not respond to biologic agents, necessitating research into the response mechanisms of biologic therapy to explore more precise treatment strategies. Preliminary work by the principal investigator has identified multiple potential responder cell subtypes to biologic agents, which may be influenced by the gut and oral microbiota. Therefore, this project proposes to investigate the mechanisms of response to biologic agents, aiming to explore more precise treatment strategies, through the integration of single-cell transcriptomics, 16S rRNA, and other multi-omics technologies on tissue samples, feces, saliva, peripheral blood, etc., from IBD patients before and after treatment. This will involve integrating bioinformatics analysis and in vitro/in vivo functional validation to elucidate the roles of treatment-responsive cell subtypes and gut and oral microbiota in the inflammatory microenvironment of the intestine, with the aim of uncovering the mechanisms of biologic agent therapy and providing new clues for the development of next-generation drug targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary non-response group | – | Drug: biologic therapy(eg:IFX,ADA,UST,VDZ)biologic therapy(eg:IFX,ADA,UST,VDZ) |
| response group | – | Drug: biologic therapy(eg:IFX,ADA,UST,VDZ)biologic therapy(eg:IFX,ADA,UST,VDZ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- based on the treating physician's judgment, The patients require biologic therapy with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) after 3 months of medication. Patients were then divided into two groups based on whether primary non-response occurred or not.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older; diagnosed with inflammatory bowel disease according to the 2019 European ECCO-ESGAR guidelines; who have not previously received any biologic therapy or, based on the treating physician's judgment, require treatment with infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ), or ustekinumab (UST) after 3 months of medication.
Key exclusion criteria (1 listed)
- Patients who refuse treatment with infliximab, adalimumab, vedolizumab, or ustekinumab for various reasons, or those with contraindications; patients currently using antibiotics or who have been in contact with probiotics/antibiotics in the past month; those with concomitant active autoimmune diseases, active tumors, etc.; those with severe oral diseases; patients experiencing other diseases unrelated to inflammatory bowel disease during treatment but may affect the efficacy of inflammatory bowel disease treatment; pregnant or lactating women; those deemed unsuitable for participation in this study by the investigator's judgment.
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 |
|---|---|---|
| biologic therapy(eg:IFX,ADA,UST,VDZ)The patients received biologic therapy during the baseline period, and the specific type of medication was determined based on the professional doctor's diagnosis and treatment opinions. Patients were then divided into two groups based on whether primary non-response occurred or not. | Drug | primary non-response group, response group |
Primary outcome
clinical response rate
Time frame: 3 months after biologic therapy began
The ratio of patients achieving clinical response to the total number of treated patients.
clinical remission rate
Time frame: 3 months after biologic therapy began
The ratio of patients achieving clinical remission to the total number of treated patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- 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 Inflammatory Bowel Diseases, run by Nanfang Hospital, Southern Medical 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 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 7 Jun 2024. 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 Xinmei Zhao (13268270713, xmzhao914@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical response rate (time frame: 3 months after biologic therapy began). 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 7 Jun 2024.