Investigation of the Correlation Between Polyamine Levels and Their Key Enzymatic Activities in Association With Inflammatory Bowel Disease Progression

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorXijing Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

IBD patients aged 18-65 years were recruited from The First Affiliated Hospital of the Air Forth Medical University.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

146 Participants
are grouped into 3 trial groups
Group A: IBD group
Group B: Healthy subjects
Group C: First-line biologics group

Trial outcomes

Primary outcomes

1

Disease activity

For patients with recent colonoscopy results: UC patients are assessed for disease activity using the modified Mayo score, while CD patients are evaluated using the SECA score. For patients without recent colonoscopy results: UC patients are assessed for disease activity using the Modified Truelove and Witts Grading System, and CD patients are evaluated using the SCAI for disease activity assessment. The modified Mayo score:Clinical remission is defined as a total score of ≤2 points and no single sub-item score \>1. Mild activity is defined as 3-5 points, moderate activity as 6-10 points, and severe activity as 11-12 points. SECA:0 \~ 2 Indicates endoscopic remission,3 \~ 6 suggests mild disease activity,7 \~ 15 indicates moderate disease activity,≥16 reflects severe disease activity. SCAI: Total score ≤4: Indicates endoscopic remission. 5-7: Suggests mild disease activity. 8-16: Reflects moderate disease activity. \>16: Signifies severe disease activity.

Time frame
at baseline
2

The level of polyamine

The levels of putrescine, spermidine, N1-acetylspermidine, ornithine, citrulline, N1-acetylspermidine, N1-acetylspermine, N8-acetylspermidine, N-acetylornithine, N1,N12-diacetylspermine, and N-acetylputrescine in serum, feces, and urine are measured using mass spectrometry. Results will be reported in nmol/L, with levels potentially reflecting disease activity.

Time frame
at baseline and 8weeks
3

Food Frequency Questionnaire

Including 9 food groups and 59 food items. The patient's total monthly polyamine intake is calculated by multiplying the total monthly consumption of each food item by its corresponding polyamine content.Total polyamine intake (mg/month) = Σ (Food consumption \[g/month\] × Polyamine content \[mg/g\])

Time frame
at baseline
4

Gastrointestinal Microbiome

Fecal samples of some participants will be collected and prepared. DNA will be extracted from the stool samples, and the V3-V4 hypervariable region of bacterial 16S rRNA gene was sequenced.

Time frame
at baseline

Secondary outcomes

1

polyamine metabolic enzymes

Intestinal mucosal sections were stained with immunohistochemistry to quantify the content and distribution of the key polyamine metabolic enzyme Ornithine Decarboxylase (ODC).

Time frame
at baseline

Other outcomes

Sponsors and contacts

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