NCT06680076

Brief Summary

This study aimed to demonstrate the characteristic lipid profile changes in patients with inflammatory bowel disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

December 12, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 6, 2024

Last Update Submit

December 10, 2024

Conditions

Keywords

IBDlipid metabolismactivity

Outcome Measures

Primary Outcomes (2)

  • Differential lipid composition between disease and healthy groups

    Differences in lipid composition between disease and healthy groups.

    14 weeks

  • Differences in lipid composition between active and remission disease

    Differences in lipid composition between active and remission disease

    14 weeks

Study Arms (2)

Disease group

Patients who have inflammation bowel disease.

Health group

Healthy people who volunteered to participate.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers and patients who have inflammation bowel disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carol

Harbin, Heilongjiang, 150001, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colon tissue and plasma

MeSH Terms

Conditions

Inflammatory Bowel DiseasesMotor Activity

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesBehavior

Study Officials

  • Hongyu D Xu, PHD

    Harbin Medical University

    STUDY DIRECTOR

Central Study Contacts

Huichao Zhang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the GI department

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 8, 2024

Study Start

December 1, 2024

Primary Completion

February 25, 2025

Study Completion

March 30, 2025

Last Updated

December 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations