NCT06995170Recruiting
Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression
Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 146 (estimated)
- First submitted
- 14 Apr 2025
- Start date
- Jan 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- Xijing Hospital
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT06995170
What you commit to
- Study type: Observational
- Planned participants: 146
- From Jan 2025 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotics or probiotics within 8 weeks prior to the start of the study.
Other illness
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.