Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients.
According to the inclusion and exclusion criteria, 152 UC patients of the First Affiliated Hospital of the Air Forth Medical University from April 2024 to December 2024 will be included. The PSQI scale was used to evaluate the sleep quality of the enrolled patients, and the overall incidence and severity of sleep disorders in UC patients will be evaluated. According to whether the PSQI score is higher than 5 points, the subjects will be divided into UC with sleep disorder group and the UC without sleep disorder group. By reviewing electronic medical records and questionnaire surveys, general clinical information of the subjects will be collected to analyze the risk factors of sleep disorders in UC patients. Mayo score and fecal calprotectin levels will be used to assess disease activity. The correlation between sleep disorders and disease activity in UC patients will be evaluated. Age-, gender-, and education level-matched healthy controls will be recruited from The First Affiliated Hospital of the Air Forth Medical University from April 2024 to December 2024. Heart rate variability will be measured to evaluate vagal nerve activity. Serum pancreatic peptide, norepinephrine, acetylcholine, and serotonin will be measured to evaluate serum neurotransmitter levels, and resting state functional magnetic resonance imaging will be used to evaluate the brain functional activity area of the subjects. Differences and correlations in autonomic nervous system function between UC with sleep disorder and UC without sleep disorder will be explored. 16s sequencing and metabolomics will be used to analyze changes in gut microbiota and metabolites. The correlation between gut microbiota and metabolites and sleep disorders in UC patients will be explored.
Study Type
OBSERVATIONAL
Enrollment
152
Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGPittsburgh Sleep Quality Index (PSQI)
PSQI is used to evaluate the sleep quality of the subjects in the last 1 month. There are 7 dimensions and 9 entries with a total score between 0 and 21, where a score higher than 5 indicates a sleep quality problem, 0 to 5 indicates good sleep quality, 6 to 10 indicates moderate sleep quality, 11 to 15 indicates poor sleep quality, and 16 to 21 indicates very poor sleep quality.
Time frame: At baseline
Disease activity
The modified Mayo score and calprotectin are used to assess the disease activity of ulcerative colitis patients.
Time frame: At baseline
Heart Rate Variability (HRV)
HRV reflects the continuous oscillations of the R-R intervals between normal heartbeats and is strongly correlated with actual vagal nerve activity. HRV thus provides a noninvasive and quantitative index of parasympathetic nervous system activity.
Time frame: At baseline
Functional Magnetic Resonance Imaging
Resting-state functional MRI (rs-fMRI) is a noninvasive imaging modality that is able to measure spontaneous low-frequency blood oxygen level-dependent signal fluctuations at rest to infer neuronal activity.
Time frame: At baseline
Neurotransmitter Agents
Serotonin, Pancreatic Polypeptide, Norepinephrine and Acetylcholine will be tested.
Time frame: 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.
Time frame: At baseline
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a widely used international universal depression screening scales. It consists of nine main entries, each with a score of 0 to 3 and a total score between 0 and 27.
Time frame: At baseline
Generalized Anxiety Disorder (GAD-7)
GAD-7 is a widely used anxiety screening scales. It includes 7 entries, each with a score of 0 to 3 and a total score between 0 and 21.
Time frame: At baseline
Inflammatory Bowel Diseases Questionnaire (IBDQ)
IBD-Q has been widely used to evaluate the quality of life of IBD patients, including 4 dimensions of bowel symptoms, systemic symptoms, emotional ability, and social ability, with a total of 32 items.18 Each item is divided into 7 levels, counting from 1 to 7, with 1 indicating the most severe degree and 7 indicating the least severe degree. The total score ranged from 32 to 224, and the higher the total score, the better the patient's quality of survival.
Time frame: At baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.