Colitis, UlcerativeSleep QualityGastrointestinal MicrobiomeAutonomic Nervous System Imbalance
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Ulcerative colitis was diagnosed according to the Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018);
* Complete medical records and signed informed consent.
Exclusion Criteria:
* Previous mental illness or taking anti-anxiety and depression drugs;
* Patients with malignant tumors of digestive system or serious diseases of organs such as heart, lung, liver and kidney function damage or diseases of blood system;
* Drugs that affect heart rate or autonomic nervous function, such as glucocorticoids, beta-blockers, calcium channel blockers, etc. have been taken within the last 2 weeks;
* People who smoke, drink alcohol, drink tea, and drink coffee within 24 hours (all stimulants, which can easily lead to excitement and affect heart rate variability);
* Other diseases associated with autonomic nervous dysfunction (such as hyperthyroidism, hypertension, atrial premature beat, ventricular premature beat, pre-excitation syndrome, left bundle branch block, right bundle branch block, etc.).
Primary outcome measure(s)
Pittsburgh Sleep Quality Index (PSQI) — At baseline 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.
Disease activity — At baseline The modified Mayo score and calprotectin are used to assess the disease activity of ulcerative colitis patients.
Heart Rate Variability (HRV) — At baseline 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.
Functional Magnetic Resonance Imaging — At baseline 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.
Neurotransmitter Agents — At baseline Serotonin, Pancreatic Polypeptide, Norepinephrine and Acetylcholine will be tested.
Gastrointestinal Microbiome — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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