Inflammatory Bowel Disease (IBD)NCT06939569
An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
An observational study of Inflammatory Bowel Disease (IBD) and Metabolic Dysfunction Associated Fatty Liver Disease, run by Shanghai East Hospital at 1 site in China.
Trial summary
Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, are currently of unknown etiology and incurable. In recent years, the incidence of IBD has increased dramatically in China, and it will become a common disease of digestive system in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Metabolic Dysfunction Associated Fatty Liver Disease
- How many people
- 337 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients diagnosed with IBD by imaging, histology and/or endoscopy in IBD Diagnosis and Treatment Center of East Hospital, Pudong New Area, Shanghai
Who may be able to join
- Subjects aged over 18 years (including borderline values), of either sex.
- Subjects consistented with the Chinese consensus on the diagnosis and treatment of IBD;
- Subjects able to cooperate with follow-up, participate in this study and sign the informed consent.
Who cannot join
- Subjects with incomplete clinical data;
- Subjects can not to cooperate with follow-up, and refuse to sign the informed consent;
- Subjects can not to cooperate with the completion of relevant examinations; 4 Pregnant women;
- 5.Subjects with severe heart, lung, kidney and other organ diseases or cancer, and expected survival time less than 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai
Lan Zhong, 8613162099450, lanzhong@tongji.edu.cn
About this study
Official title: A Bidirectional, Multicenter Cohort Study of Inflammatory Bowel Disease (IBD) Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, are currently of unknown etiology and incurable. In recent years, the incidence of IBD has increased dramatically in China, and it will become a common disease of digestive system in China. Mesenteric adipose tissue hyperplasia indicates disease activity in IBD patients, and abnormal lipid metabolism plays an important role in the pathogenesis of IBD.
In addition to intestinal symptoms, nonalcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction associated fatty liver disease (MASLD), has become the most common extraintinal manifestation in IBD patients. What are the similarities and differences between IBD patients with and without MASLD? Does the occurrence and severity of MASLD affect the clinical efficacy of IBD and increase the adverse outcome of IBD? There are no relevant studies to date. We have previously completed the construction of a cohort of 290 IBD patients using the IBD patient database and biobank of Dongfang Hospital, based on which we completed a cohort study on the effect of small intestinal bacterial overgrowth on IBD disease activity. Based on this cohort, multi-center cooperation was carried out to establish an IBD research cohort by collecting basic clinical information and biological samples such as peripheral blood and intestinal mucosa. The clinical characteristics of IBD patients with MASLD were analyzed. logistic regression, COX regression, Kaplan-Meier survival curve and other methods were used. To investigate the effect of MASLD on the clinical efficacy and prognosis of inflammatory bowel disease (IBD). This project will provide efficient, full and reliable research-grade data with Chinese characteristics for IBD clinical research, and improve the level of regional diagnosis and treatment.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| IBD with MASLD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission or Endoscopic remission
Clinical remission (CDAI≤150 in CD patients, Mayo≤2 in UC patients); Endoscopic remission (SES-CD in CD patients and UCEIS in UC patients with > 50% improvement from baseline)
Measured: Follow-up for 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies 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
- 337 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pudong New Area Health Commission, Dongfang Hospital Affiliated to Tongji University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939569
- Sponsor's protocol ID
- 2024-PWDL-01
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bidirectional, Multicenter Cohort Study of Inflammatory Bowel Disease (IBD) Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT06939569
- Acronym / sponsor ID
- 2024-PWDL-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 337 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Shanghai Pudong New Area Health Commission, Dongfang Hospital Affiliated to Tongji University
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Apr 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.
Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, are currently of unknown etiology and incurable. In recent years, the incidence of IBD has increased dramatically in China, and it will become a common disease of digestive system in China. Mesenteric adipose tissue hyperplasia indicates disease activity in IBD patients, and abnormal lipid metabolism plays an important role in the pathogenesis of IBD.
In addition to intestinal symptoms, nonalcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction associated fatty liver disease (MASLD), has become the most common extraintinal manifestation in IBD patients. What are the similarities and differences between IBD patients with and without MASLD? Does the occurrence and severity of MASLD affect the clinical efficacy of IBD and increase the adverse outcome of IBD? There are no relevant studies to date. We have previously completed the construction of a cohort of 290 IBD patients using the IBD patient database and biobank of Dongfang Hospital, based on which we completed a cohort study on the effect of small intestinal bacterial overgrowth on IBD disease activity. Based on this cohort, multi-center cooperation was carried out to establish an IBD research cohort by collecting basic clinical information and biological samples such as peripheral blood and intestinal mucosa. The clinical characteristics of IBD patients with MASLD were analyzed. logistic regression, COX regression, Kaplan-Meier survival curve and other methods were used. To investigate the effect of MASLD on the clinical efficacy and prognosis of inflammatory bowel disease (IBD). This project will provide efficient, full and reliable research-grade data with Chinese characteristics for IBD clinical research, and improve the level of regional diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD with MASLD | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with IBD by imaging, histology and/or endoscopy in IBD Diagnosis and Treatment Center of East Hospital, Pudong New Area, Shanghai
Key inclusion criteria (3 listed)
- Subjects aged over 18 years (including borderline values), of either sex.
- Subjects consistented with the Chinese consensus on the diagnosis and treatment of IBD;
- Subjects able to cooperate with follow-up, participate in this study and sign the informed consent.
Key exclusion criteria (4 listed)
- Subjects with incomplete clinical data;
- Subjects can not to cooperate with follow-up, and refuse to sign the informed consent;
- Subjects can not to cooperate with the completion of relevant examinations; 4 Pregnant women;
- 5.Subjects with severe heart, lung, kidney and other organ diseases or cancer, and expected survival time less than 6 months.
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
Clinical remission or Endoscopic remission
Time frame: Follow-up for 54 weeks
Clinical remission (CDAI≤150 in CD patients, Mayo≤2 in UC patients); Endoscopic remission (SES-CD in CD patients and UCEIS in UC patients with > 50% improvement from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Disease (IBD) and Metabolic Dysfunction Associated Fatty Liver Disease, run by Shanghai East 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan Zhong, MD (8613162099450, lanzhong@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission or Endoscopic remission (time frame: Follow-up for 54 weeks). 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 23 Apr 2025.