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NCT Number: NCT06995170

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infliximab Intestinal Diseases Polyamines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Disease activity

    Time frame: at baseline

    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.

  2. The level of polyamine

    Time frame: at baseline and 8weeks

    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.

  3. Food Frequency Questionnaire

    Time frame: at baseline

    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])

  4. Gastrointestinal Microbiome

    Time frame: at baseline

    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.

Secondary outcomes

  1. polyamine metabolic enzymes

    Time frame: at baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Zhang

CONTACT

[email protected]

+8613677056116

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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