Crohn's DiseaseNCT07035678
A Study on the Associations of Toll-like Receptor 5 Gene Polymorphisms With Crohn's Disease in Chinese Patients
An observational study of Crohn's Disease and Ustekinumab, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The exact etiology and pathogenesis of Crohn's disease (CD) have not been fully elucidated, and may be related to the combined effects of genetics, environment, immunity, gut microbiota, and many other factors. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Ustekinumab, Toll-like Receptor 5
- How many people
- 825 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 May 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese
Who may be able to join
- After receiving IFX conventional treatment plan for 30 weeks;
- Not participated in any other experimental projects in the past three months;
- There are no other serious and life-threatening diseases in various systems.
Who cannot join
- Pregnancy;
- Breastfeeding;
- Severe drug allergy (having experienced severe drug allergic reactions such as anaphylactic shock, systemic dermatitis, etc.);
- Merge with other autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroiditis);
- Merge malignant tumors;
- Serious cardiovascular and cerebrovascular diseases;
- Poor patient compliance or presence of mental disorders;
- Incomplete case data.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
The exact etiology and pathogenesis of Crohn's disease (CD) have not been fully elucidated, and may be related to the combined effects of genetics, environment, immunity, gut microbiota, and many other factors. Toll like receptor 5 (TLR5) is one of the transmembrane pattern recognition receptors that specifically recognizes and binds to bacterial flagellar proteins, activating the nuclear factor kappa-B (NF - κ B) signaling pathway and triggering immune and inflammatory responses. The TLR5 gene is located in the 1q33.3 region of the human chromosome, with a total length of approximately 34kb and 6 exons. Research data from European populations shows that two single nucleotide polymorphisms, rs5744168 and rs5744174, in the TLR5 gene may be closely associated with the risk of developing CD. According to Danish scholars, the mutation of rs5744174 may affect the clinical response of CD patients treated with anti-tumor necrosis factor - α (TNF - α) drugs.
Ustekinumab (UST) is a fully humanized monoclonal antibody against the p40 subunit and is one of the commonly used biologics for treating CD patients. The p40 subunit is a common component of interleukin-12 (IL) and IL-23, therefore UST can simultaneously inhibit the IL-12 and IL-23 signaling pathways, exerting anti-inflammatory effects by suppressing immune cell differentiation such as T helper cell 1 (Th1), Th17 cells, natural killer cells, macrophages, etc. Among CD patients receiving UST treatment, it was found that patients who achieved clinical response in the early stage were more likely to achieve clinical remission in the middle and later stages compared to those who did not , indicating that evaluating early response has certain clinical value in predicting the efficacy of UST in the middle and later stages. This study aims to explore the relationship between TLR5 (rs5744168 and rs5744174) gene polymorphism and the risk and clinical pathological characteristics of CD in the Han population of Zhejiang, and analyze whether TLR5 gene mutations affect the early response of UST treatment for CD patients. The aim is to provide some clues and basis for revealing the genetic and immunological pathogenesis of CD and developing precise individualized treatment plans for UST.
- 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 |
|---|---|---|
| Crohn's disease group | Diagnosed with Crohn's disease. | |
| Normal control group | Healthy individuals without a history of rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvey Bradshaw Index
mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25
Measured: 8 weeks
TLR5 gene polymorphisms
Measured: 0 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jan 2019
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035678
- Sponsor's protocol ID
- SAHoWMU-CR2025-01-221
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Associations of Toll-like Receptor 5 Gene Polymorphisms With Crohn's Disease in Chinese Patients
- ClinicalTrials.gov ID
- NCT07035678
- Acronym / sponsor ID
- SAHoWMU-CR2025-01-221
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 Jun 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.
The exact etiology and pathogenesis of Crohn's disease (CD) have not been fully elucidated, and may be related to the combined effects of genetics, environment, immunity, gut microbiota, and many other factors. Toll like receptor 5 (TLR5) is one of the transmembrane pattern recognition receptors that specifically recognizes and binds to bacterial flagellar proteins, activating the nuclear factor kappa-B (NF - κ B) signaling pathway and triggering immune and inflammatory responses. The TLR5 gene is located in the 1q33.3 region of the human chromosome, with a total length of approximately 34kb and 6 exons. Research data from European populations shows that two single nucleotide polymorphisms, rs5744168 and rs5744174, in the TLR5 gene may be closely associated with the risk of developing CD. According to Danish scholars, the mutation of rs5744174 may affect the clinical response of CD patients treated with anti-tumor necrosis factor - α (TNF - α) drugs.
Ustekinumab (UST) is a fully humanized monoclonal antibody against the p40 subunit and is one of the commonly used biologics for treating CD patients. The p40 subunit is a common component of interleukin-12 (IL) and IL-23, therefore UST can simultaneously inhibit the IL-12 and IL-23 signaling pathways, exerting anti-inflammatory effects by suppressing immune cell differentiation such as T helper cell 1 (Th1), Th17 cells, natural killer cells, macrophages, etc. Among CD patients receiving UST treatment, it was found that patients who achieved clinical response in the early stage were more likely to achieve clinical remission in the middle and later stages compared to those who did not , indicating that evaluating early response has certain clinical value in predicting the efficacy of UST in the middle and later stages. This study aims to explore the relationship between TLR5 (rs5744168 and rs5744174) gene polymorphism and the risk and clinical pathological characteristics of CD in the Han population of Zhejiang, and analyze whether TLR5 gene mutations affect the early response of UST treatment for CD patients. The aim is to provide some clues and basis for revealing the genetic and immunological pathogenesis of CD and developing precise individualized treatment plans for UST.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease group | – | –Diagnosed with Crohn's disease. |
| Normal control group | – | –Healthy individuals without a history of rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (3 listed)
- After receiving IFX conventional treatment plan for 30 weeks;
- Not participated in any other experimental projects in the past three months;
- There are no other serious and life-threatening diseases in various systems.
Key exclusion criteria (8 listed)
- Pregnancy;
- Breastfeeding;
- Severe drug allergy (having experienced severe drug allergic reactions such as anaphylactic shock, systemic dermatitis, etc.);
- Merge with other autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroiditis);
- Merge malignant tumors;
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
Harvey Bradshaw Index
Time frame: 8 weeks
mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25
TLR5 gene polymorphisms
Time frame: 0 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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's Disease and Ustekinumab, run by Second Affiliated Hospital of Wenzhou 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 25 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvey Bradshaw Index (time frame: 8 weeks). 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 25 Jun 2025.