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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06995170

KY20242438

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

146 participants in 3 patient groups

IBD group

Description:

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

Description:

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

Description:

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.