Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression
Recruiting now
Conditions studied: Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Polyamines, Infliximab
In brief
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.
Key facts
- Study ID
- NCT06995170
- Run by
- Xijing Hospital
- People needed
- 146
- Starts
- 2025-01-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-05-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Presence of other metabolic disorders;
- History of malignant tumors, severe organ dysfunction, or other severe systemic diseases affecting major organs, or hematological disorders;
- Diagnosis of influenza, bacterial dysentery, or other infectious diseases within the past 2 weeks;
- Presence of other diseases that may interfere with polyamine metabolism;
- Use of antibiotics or probiotics within 8 weeks prior to the start of the study.
Where it is running
- Xijing Hospital — Xi'an, Shaanxi, China (enrolling)
Full record on ClinicalTrials.gov
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