Actively Recruiting
A Study Based on the Microbiota-gut-brain Axis to Explore the Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
Led by Xijing Hospital · Updated on 2025-12-31
152
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the clinical characteristics of sleep disorders in patients with ulcerative colitis (UC), a type of inflammatory bowel disease that significantly impacts patients' quality of life. This study focuses on how sleep disorders, which affect over 60% of inflammatory bowel disease patients, influence the occurrence and progression of UC through the microbiota-gut-brain axis. The goal is to understand the effects of sleep problems on the autonomic nervous system, gut bacteria, and metabolites in UC patients. The study will enroll 152 UC patients aged 18 to 65 years and healthy control participants matched by age, gender, and education level. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) to categorize participants into groups with or without sleep disorders. Researchers will collect clinical data, assess disease activity with Mayo scores and fecal calprotectin, and measure heart rate variability to evaluate vagal nerve function. They will also analyze serum neurotransmitters and use brain imaging to study functional brain activity. Gut microbiota and metabolites will be examined through sequencing and metabolomics. Participants will undergo various evaluations including questionnaires on sleep quality, mood, and inflammatory bowel disease symptoms. Blood and stool samples will be collected for laboratory tests. Heart rate variability and brain scans will be performed to assess nervous system function. The study will measure outcomes like sleep quality, disease activity, autonomic function, brain activity, neurotransmitter levels, and gut microbiome changes. The study is planned from April to December 2024, with continuing follow-up until June 2026.
CONDITIONS
Brief Title
Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ulcerative colitis diagnosed according to the Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)
- Complete medical records available
- Signed informed consent provided
You will not qualify if you...
- History of mental illness or use of anti-anxiety or depression medications
- Malignant tumors of the digestive system or serious diseases affecting heart, lung, liver, kidney, or blood system
- Use of drugs affecting heart rate or autonomic function (e.g., glucocorticoids, beta-blockers, calcium channel blockers) within the last 2 weeks
- Use of stimulants such as smoking, alcohol, tea, or coffee within 24 hours
- Other diseases associated with autonomic nervous dysfunction (e.g., hyperthyroidism, hypertension, arrhythmias, bundle branch block)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants undergo various assessments including sleep quality evaluation, disease activity measurement, heart rate variability, brain imaging, neurotransmitter levels, and gut microbiome analysis.
1 visit (in-person)
Duration - Up to 8 months (April 2024 to December 2024)
Participants' clinical information and questionnaire survey data are collected and analyzed to explore correlations and risk factors related to sleep disorders in ulcerative colitis.
Data collected from medical records and questionnaires
Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
J
Jiaming Zhou
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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