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

NCT06995170 | Recruiting

• 1 other identifier: KY20242438
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Polyamines; Infliximab

Outcome Measures

Primary Outcomes (4)

• 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.

  at baseline

• 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.

  at baseline and 8weeks

• 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 \[mg/g\])

  at baseline

• 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.

  at baseline

Secondary Outcomes (1)

• polyamine metabolic enzymes

  at baseline

Study Arms (3)

IBD group

IBD patients aged 18-65 years were categorized into remission and active-phase groups according to corresponding clinical scoring scales. IBD patients will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025.

Healthy subjects

Age-, gender-, and education level-matched healthy controls will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025.

First-line biologics group

18-65-year-old Inflammatory Bowel Disease (IBD) patients planned for the first administration of Infliximab will be recruited from The First Affiliated Hospital of the Air Forth Medical University from January 2025 to December 2025.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Use of antibiotics or probiotics within 8 weeks prior to the start of the study.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fecal ,plasma, urine and fixed tissue samples of some participants will be collected

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Kaichun Wu

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Zhang

CONTACT

+8613677056116; 514602793@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 29, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)