Examining the link between polyamine levels and inflammatory bowel disease progression
Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression
Xijing Hospital · NCT06995170
This study is trying to see if measuring certain substances in the body can help predict how inflammatory bowel diseases like Ulcerative Colitis and Crohn's Disease will progress in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xijing Hospital (other) |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06995170 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how polyamine levels and their associated enzymatic activities correlate with the progression of inflammatory bowel diseases (IBD), including Ulcerative Colitis and Crohn's Disease. It aims to establish a predictive model for IBD progression by measuring polyamine and metabolite levels, as well as assessing the efficacy of biologics through polyamine detection. The study will involve 91 patients diagnosed with IBD and 46 healthy controls, utilizing high-performance liquid chromatography and mass spectrometry for analysis. Additionally, it will explore gut microbiota alterations related to polyamine metabolism to provide insights for probiotic guidance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 diagnosed with inflammatory bowel disease.
Not a fit: Patients with other metabolic disorders or severe systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients with inflammatory bowel disease.
How similar studies have performed: While the approach of correlating polyamine levels with IBD progression is relatively novel, similar studies have shown promise in understanding metabolic pathways in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an, Shaanxi
- Xijing Hospital — Xi'an, Shaanxi, China (RECRUITING)
Study contacts
- Principal investigator: Kaichun Wu — Xijing Hospital
- Study coordinator: Hao Zhang
- Email: 514602793@qq.com
- Phone: +8613677056116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Polyamines, Infliximab