Exploring sleep disorders in ulcerative colitis patients
A Study Based on the Microbiota-gut-brain Axis to Explore the Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
Xijing Hospital · NCT06359808
This study looks at how sleep problems affect people with ulcerative colitis and what that means for their overall health and gut bacteria.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Xijing Hospital (other) |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06359808 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the clinical characteristics of patients with ulcerative colitis (UC) who experience sleep disorders. It aims to analyze the impact of sleep quality on the autonomic nervous system, gut microbiota, and metabolites in UC patients. A total of 152 UC patients will be recruited, and their sleep quality will be assessed using the PSQI scale. The study will also evaluate disease activity through Mayo scores and fecal calprotectin levels, while comparing findings with age-, gender-, and education-matched healthy controls.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with ulcerative colitis who are willing to participate and provide informed consent.
Not a fit: Patients with previous mental illnesses or those taking medications that affect autonomic nervous function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the relationship between sleep disorders and ulcerative colitis, potentially leading to improved management strategies for affected patients.
How similar studies have performed: While the relationship between sleep disorders and inflammatory bowel disease has been noted, this specific approach focusing on the microbiota-gut-brain axis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.).
Where this trial is running
Xi'an, Shaanxi
- Xijing Hospital — Xi'an, Shaanxi, China (RECRUITING)
Study contacts
- Principal investigator: Kaichun Wu — Xijing Hospital
- Study coordinator: Jiaming Zhou
- Email: 1041181972@qq.com
- Phone: +86 173 9207 9496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colitis, Ulcerative, Sleep Quality, Gastrointestinal Microbiome, Autonomic Nervous System Imbalance