NCT06359808Recruiting
Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
A Study Based on the Microbiota-gut-brain Axis to Explore the Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 152 (estimated)
- First submitted
- 6 Apr 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Xijing Hospital
- Diseases
- Ulcerative colitis
- NCT number
- NCT06359808
What you commit to
- Study type: Observational
- Planned participants: 152
- From 1 Apr 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous mental illness or taking anti-anxiety and depression drugs;
Other illness
- 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;
- 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.).
Lab values
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.