NCT06995170 Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression
| NCT ID | NCT06995170 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 146 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 146 participants in total. It began in 2025-01-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age between 18 and 65 years; 2. 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); 3. Complete medical records available and written informed consent obtained from the participant. Exclusion Criteria: 1. Presence of other metabolic disorders; 2. History of malignant tumors, severe organ dysfunction, or other severe systemic diseases affecting major organs, or hematological disorders; 3. Diagnosis of influenza, bacterial dysentery, or other infectious diseases within the past 2 weeks; 4. Presence of other diseases that may interfere with polyamine metabolism; 5. Use of antibiotics or probiotics within 8 weeks prior to the start of the study.
Contact & Investigator
Kaichun Wu
PRINCIPAL INVESTIGATOR
Xijing Hospital
Frequently Asked Questions
Who can join the NCT06995170 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06995170 currently recruiting?
Yes, NCT06995170 is actively recruiting participants. Contact the research team at 514602793@qq.com for enrollment information.
Where is the NCT06995170 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06995170 clinical trial?
NCT06995170 is sponsored by Xijing Hospital. The principal investigator is Kaichun Wu at Xijing Hospital. The trial plans to enroll 146 participants.