Inflammatory Bowel DiseasesNCT06680076
Study on Lipid Profile Changes in Plasma and Intestinal Mucosa of Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to 30 Mar 2025
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and patients who have inflammation bowel disease.
Who may be able to join
- Patients with inflammatory bowel disease; aged 18-80 years; all cases agreed to participate in the study.
- Healthy volunteers who agreed to participate in the study.
Who cannot join
- Patients with severe heart disease; patients with severe kidney disease; patients with low blood pressure; patients with severe infections such as sepsis or pneumonia; patients who have used immunosuppressants such as 6-mercaptopurine, imidazole thiopurine, and cyclosporine within a short period, and women during pregnancy; patients who are post-colon resected; patients who disagreed to participate in the study.
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
Carol
Harbin, Heilongjiang, 150001
Huichao D Zhang, 13945003159, zhanghuichao0609@163.com
About this study
Official title: Observational Study of Changes in Plasma and Intestinal Mucosa Lipid Profiles in Patients With Inflammatory Bowel Disease
This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.
Read the detailed description
This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.
The investigators followed up with patients with different stages of IBD and collected plasma and lesion tissues from patients and healthy volunteers for lipid metabolism-related substances to assess the changes in lipid metabolism in patients with different stages of IBD and their impact on disease.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD, lipid metabolism, activity
- Medical subject headings
- Inflammatory Bowel Diseases, Motor Activity
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 |
|---|---|---|
| Disease group | Patients who have inflammation bowel disease. | |
| Health group | Healthy people who volunteered to participate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential lipid composition between disease and healthy groups
Differences in lipid composition between disease and healthy groups.
Measured: 14 weeks
Differences in lipid composition between active and remission disease
Differences in lipid composition between active and remission disease
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study startDec 2024 (estimated)
- Primary completion25 Feb 2025 (estimated)
- Study completion30 Mar 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.
- 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
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyu Xu, First Affiliated Hospital of Harbin Medical University
- Investigators
- Hongyu D Xu, PHD, Study director, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680076
- Sponsor's protocol ID
- Harbin Medical University
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Changes in Plasma and Intestinal Mucosa Lipid Profiles in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06680076
- Acronym / sponsor ID
- Harbin Medical University
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD, lipid metabolism, activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 8 Nov 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.
This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.
Detailed description
This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.
The investigators followed up with patients with different stages of IBD and collected plasma and lesion tissues from patients and healthy volunteers for lipid metabolism-related substances to assess the changes in lipid metabolism in patients with different stages of IBD and their impact on disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease group | – | –Patients who have inflammation bowel disease. |
| Health group | – | –Healthy people who volunteered to participate. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patients who have inflammation bowel disease.
Key inclusion criteria (2 listed)
- Patients with inflammatory bowel disease; aged 18-80 years; all cases agreed to participate in the study.
- Healthy volunteers who agreed to participate in the study.
Key exclusion criteria (1 listed)
- Patients with severe heart disease; patients with severe kidney disease; patients with low blood pressure; patients with severe infections such as sepsis or pneumonia; patients who have used immunosuppressants such as 6-mercaptopurine, imidazole thiopurine, and cyclosporine within a short period, and women during pregnancy; patients who are post-colon resected; patients who disagreed to participate in 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
Differential lipid composition between disease and healthy groups
Time frame: 14 weeks
Differences in lipid composition between disease and healthy groups.
Differences in lipid composition between active and remission disease
Time frame: 14 weeks
Differences in lipid composition between active and remission disease
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 12 Dec 2024.
- 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.
Hongyu D Xu, PHD study director
Harbin Medical University
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 First Affiliated Hospital of Harbin 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 2 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: opening soon, as of the sponsor's last update on 12 Dec 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?
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 Huichao Zhang, MD (13945003159 ext. 0451-85555119, zhanghuichao0609@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential lipid composition between disease and healthy groups (time frame: 14 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 12 Dec 2024.