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Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression
NCT06995170 · Xijing Hospital
In plain English
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About this study
According to the inclusion and exclusion criteria, 91 patients with IBD diagnosed in the Department of Gastroenterology, the First Affiliated Hospital of Air Force Medical University from November 2024 to September 2025 were included, and the subjects were divided into remission group and active group according to the corresponding IBD scale scores; 46 healthy controls were generally included according to the number of patients; In addition, 47 patients in the first biologic treatment group were included according to the inclusion and exclusion criteria. The FFQ scale was used to calculate and evaluate the intake of polyamines in the enrolled patients, high performance liquid chromatography and mass spectrometry were used to measure the levels of polyamines in serum and fecal samples of patients, and immunohistochemical semi quantitative analysis of colon pathological sections was used to analyze the levels of key enzymes of polyamine metabolism.
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.
Study design
Enrollment target: 146 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-01-01
Estimated completion: 2025-12
Last updated: 2025-05-29
Primary outcomes
- • Disease activity (at baseline)
- • The level of polyamine (at baseline and 8weeks)
- • Food Frequency Questionnaire (at baseline)
Sponsor
Xijing Hospital · other
Contacts & investigators
ContactHao Zhang · contact · 514602793@qq.com · +8613677056116
InvestigatorKaichun Wu · principal_investigator, Xijing Hospital
All locations (1)
Xijing HospitalRecruiting
Xi'an, Shaanxi, China