Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Inflammatory Bowel Disease (IBD), encompassing Ulcerative Colitis (UC) and Crohn's Disease (CD), significantly impairs patients' quality of life. Current monitoring of disease activity primarily relies on endoscopy combined with histological examination, which is associated with high costs, invasiveness, poor patient tolerance, and risks of complications. Additionally, disease activity indices and laboratory-based IBD staging metrics demonstrate limited utility and accuracy in clinical practice. This study aims to investigate the correlation between polyamine levels and their key enzymes in the polyamine metabolism pathway with IBD activity, thereby establishing a predictive model for IBD progression through polyamine and metabolite measurements; to estimate the efficacy of biologics via polyamine detection, providing a scientific basis for therapeutic selection; and to screen gut microbiota associated with polyamine metabolic alterations, offering evidence-based guidance for probiotic selection in IBD patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Age between 18 and 65 years;

• Diagnosed with inflammatory (IBD) according to the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an) and the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou);

• Complete medical records available and written informed consent obtained from the participant.

Locations
Other Locations
China
Xijing Hospital
RECRUITING
Xi'an
Contact Information
Primary
Hao Zhang
514602793@qq.com
+8613677056116
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 146
Treatments
IBD group
IBD patients aged 18-65 years were categorized into remission and active-phase groups according to corresponding clinical scoring scales. IBD patients will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025.
Healthy subjects
Age-, gender-, and education level-matched healthy controls will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025.
First-line biologics group
18-65-year-old Inflammatory Bowel Disease (IBD) patients planned for the first administration of Infliximab will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025.
Sponsors
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov