Colitis, UlcerativeNCT06359808
Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
An observational study of Colitis, Ulcerative and Sleep Quality, run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colitis, Ulcerative, Sleep Quality, Gastrointestinal Microbiome
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ulcerative colitis patients aged 18-65 years were recruited from The First Affiliated Hospital of the Air Forth Medical University.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Jiaming Zhou, +8617392079496, 1041181972@qq.com
About this study
Official title: A Study Based on the Microbiota-gut-brain Axis to Explore the Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
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.
Read the detailed description
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.
- Conditions
- Colitis, Ulcerative, Sleep Quality, Gastrointestinal Microbiome, Autonomic Nervous System Imbalance
- Medical subject headings
- Colitis, Ulcerative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis group | Ulcerative colitis patients aged 18-65 years will be recruited from The First Affiliated Hospital of the Air Forth Medical University from April 2024 to December 2024. | |
| Healthy subjects | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh 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.
Measured: At baseline
Disease activity
The modified Mayo score and calprotectin are used to assess the disease activity of ulcerative colitis patients.
Measured: 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.
Measured: 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.
Measured: At baseline
Neurotransmitter Agents
Serotonin, Pancreatic Polypeptide, Norepinephrine and Acetylcholine will be tested.
Measured: 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.
Measured: At baseline
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaichun Wu, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359808
- Sponsor's protocol ID
- KY20232370
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Based on the Microbiota-gut-brain Axis to Explore the Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06359808
- Acronym / sponsor ID
- KY20232370
- Conditions
- Colitis, Ulcerative, Sleep Quality, Gastrointestinal Microbiome, Autonomic Nervous System Imbalance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis group | – | –Ulcerative colitis patients aged 18-65 years will be recruited from The First Affiliated Hospital of the Air Forth Medical University from April 2024 to December 2024. |
| Healthy subjects | – | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ulcerative colitis patients aged 18-65 years were recruited from The First Affiliated Hospital of the Air Forth Medical University.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Time frame: At baseline
The modified Mayo score and calprotectin are used to assess the disease activity of ulcerative colitis patients.
Heart Rate Variability (HRV)
Time frame: 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
Time frame: 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
Time frame: At baseline
Serotonin, Pancreatic Polypeptide, Norepinephrine and Acetylcholine will be tested.
Gastrointestinal Microbiome
Time frame: 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.
3 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: At baseline
Generalized Anxiety Disorder (GAD-7)
Time frame: At baseline
Inflammatory Bowel Diseases Questionnaire (IBDQ)
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaichun Wu principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis, Ulcerative and Sleep Quality, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaming Zhou (+86 173 9207 9496, 1041181972@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.