Circadian Rhythm DisordersNCT05694481
An Observational Clinical Study on the Intestinal Flora in Circadian Rhythm Disorder and Healthy Controls
An observational study of Circadian Rhythm Disorders and Intestinal Flora, run by Third Military Medical University at 1 site in China.
Trial summary
An observational clinical study on the changes of intestinal flora between people with circadian rhythm disorders and healthy controls was conducted to explore the relationship between circadian rhythm disorders and human intestinal microorganisms. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm Disorders, Intestinal Flora
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2023to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects of the study will recruit employees with certain regularity who are engaged in night or day shifts from Daping Hospital of Army Medical University.
Who may be able to join
- All genders, Age18~75,
- Regular night shift or day shift,
- No antibiotics and probiotics within one month,
- Possess understanding and communicate ability；no severe disease，no mental disorders,
- Fully informed consent, willing to participate in this study.
Who cannot join
- Not willing to participate in this study,
- Patients with severe cognitive impairment or mental illness,
- Alcohol and drug dependence,
- The sleep disorder by alcohol and Coffee and/or Strong tea,
- No other Tranquilizers treatment was received within 1 week before the drug was used in this clinical trial,
- Severe intestinal infection, such as salmonella, shigella, pestis, etc,
- Pregnant or lactating women,
- Other reasons not suitable for clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Daping Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Yanling Wei, MD, 86-15310354666, lingzi016@126.com
About this study
Official title: Effect of Circadian Rhythm Disorder on Human Intestinal Microbiota
An observational clinical study on the changes of intestinal flora between people with circadian rhythm disorders and healthy controls was conducted to explore the relationship between circadian rhythm disorders and human intestinal microorganisms. To reveal the effects of circadian rhythm disorder on human intestinal microorganisms and metabolism on other potential diseases. In this study, 40 people with circadian disorders and 40 healthy controls were recruited. During the study, blood, urine and fecal samples of the subjects were obtained once, and the obtained biological samples were tested and analyzed by serum, urine metabolomics and fecal metagenomics. Subjects were also evaluated on the following scales : Circadian Type Inventory（CTI ）. The Epworth Sleeping Scale ( ESS ), Fatigue Scale-14 ( FS-14 ), Maslach Burnout Inventory-General Survey ( MBI-GS ), Athens Insomnia Scale ( AIS ), Insomnia Severity Index ( ISI ), Pittsburgh sleep quality index ( PSQI ), Bristol Stool Scale, Gastrointestinal Symptom Rating Scale ( GSRS ), Connor-Davidson resi.
Read the detailed description
This study will explore the relationship between circadian rhythm disorders and human intestinal flora. The subjects were included in strict accordance with the inclusion criteria. Feces, blood, urine or other biological samples were collected and analyzed. The clinical data assessment scale and biological samples of the subjects were collected only once.
- Data management The case report form ( CRF ) is a way of recording clinical data in clinical trials. The researchers should record all the relevant data of each subject in the experiment in a timely and true manner, and make confirmation and signature. CRF should not be changed at will. Researchers should sign and indicate the date when they do need to change. After the end of the trial, CRF was preserved by the clinical trial institution and sponsor of the researcher 's hospital. The completed CRF is reviewed by the clinical inspector and data entry is performed without modification. In order to ensure the privacy of subjects, the names of subjects on CRF need to use codes.
- Statistical analysis The statistical analysis plan should be formulated after the finalization of the plan and finalized before the database is locked. The statistical analysis plan will specify and describe all the statistical analysis contents according to the main characteristics of the plan.
- Preservation of data All clinical data and data analysis were recorded and managed by researchers.
- Ethics Committee : Ethics Committee of Army Characteristic Medical Center of PLA. Application procedure : fill in the application form of ethical approval and attach the relevant approval materials.
- Informed consent : The investigator must explain to each participant the nature, purpose, procedure, expected time, potential risks and benefits, and any discomfort that may arise, of the trial. Each subject must know that participation in the trial is voluntary and that he / she can withdraw from the trial at any time and withdraw his / her informed consent without affecting his / her subsequent treatment or relationship with the treating hysician. After explaining the basic content of the test and the researchers have been convinced that each participant will understand the purpose of the test, each participant should be required to sign the name and date on the informed consent form. Subjects should read and consider their tatements before signing and dated, and should obtain a copy of the informed consent form after signing. Subjects could not enter the trial without informed consent and without signed informed consent.
- Conditions
- Circadian Rhythm Disorders, Intestinal Flora
- Keywords
- Circadian rhythm, Gut microbiota, Metabolomics, Metagenomes
- Medical subject headings
- Chronobiology 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 |
|---|---|---|
| Circadian rhythm disorders | Observational, no intervention administered. | |
| Healthy controls | Observational, no intervention administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gut microbiota
Alpha and Beta diversity of gut microbiota by metagenome. function and sequence-based analysis of gut microbiota microbial genome. The differential flora was obtained through differential analysis, and the correlation analysis was carried out between the differential flora and the differential metabolites. The difference in gut microbiota between people with circadian rhythm disorder and health controls is understood through stool detection.
Measured: Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Secondary outcomes (10)
Changes in metabolites of gut microbiota
The comprehensive and quantitative analysis of the wide arrays of metabolites in biological samples (Fecal). After the difference metabolites are obtained through the difference analysis, the large sample data are analyzed (principal co-coordinates analysis, α/β Diversity, PLS-DA, etc.). We can more fully understand the relationship between intestinal microorganisms and circadian rhythm through metabonomic analysis.
Measured: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Changes of serum metabolites
The comprehensive and quantitative analysis of the wide arrays of metabolites in biological samples (Serum). After the difference metabolites are obtained through the difference analysis, the large sample data are analyzed (principal co-coordinates analysis, α/β Diversity, PLS-DA, etc.). Through metabolites analysis, we can more comprehensively understand the relationship between intestinal microorganisms and circadian rhythm and blood metabolites.
Measured: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Changes of urine metabolites
The comprehensive and quantitative analysis of the wide arrays of metabolites in biological samples (Urine). After the difference metabolites are obtained through the difference analysis, the large sample data are analyzed (principal co-coordinates analysis, α/β Diversity, PLS-DA, etc.). Through metabolites analysis, we can more comprehensively understand the relationship between intestinal microorganisms and circadian rhythm and urine metabolites.
Measured: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Circadian Type Inventory
The amplitude and stability of their rhythms using questionnaires. (Circadian Type Inventory) CTI includes two subscales, of which the Flexibility/Rigidity scale has five items. The higher the score, the stronger the flexibility of rhythm. Languid/Vigorous has six items, and the higher the score, the more serious the fatigue of the human body.
Measured: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Gastrointestinal Symptom Rating Scale (GSRS)
The GSRS is a brief, fairly comprehensive assessment of common gastrointestinal symptoms. The total score is 112. The higher the score, the more serious the gastrointestinal symptoms.
Measured: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
The Epworth Sleeping Scale（ESS）
The Epworth sleepiness scale (ESS) is a widely used tool which has been validated as a measure of sleepiness. The total score is 24 points. The higher the score, the more serious the sleepiness.
Measured: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Fatigue Scale-14（FS-14）
Evaluate the severity of people's fatigue. The total score is 14 points. The higher the score, the more fatigue.
Measured: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Maslach Burnout Inventory-General Survey（MBI-GS）
The AIS is a self-assessment psychometric instrument designed for quantifying sleep difficulty based on the ICD-10 criteria. The total score is 21 points. The higher the score, the more serious the insomnia.
Measured: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Athens Insomnia Scale（AIS）
The Maslach Burnout Inventory-General Survey (MBI-GS) is a widely used scale that measures burnout in the general professions. Use the standard 100 point scale for calculation. After scoring more than 50 points, the higher the score, the less positive the attitude towards work.
Measured: Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
The Depression Anxiety Stress Scale (DASS)
The DASS-21 can validly be used to measure the dimensions of depression, anxiety, and stress. The total score is 63 points. The higher the score, the worse the mental state.
Measured: Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm DisordersStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanling Wei, Third Military Medical University
- Investigators
- Yanling Wei*, MD, Principal investigator, Daping Hospital, Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694481
- Sponsor's protocol ID
- 20221201
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2022
- Last updated
- 23 Jan 2023
- 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 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Circadian Rhythm Disorder on Human Intestinal Microbiota
- ClinicalTrials.gov ID
- NCT05694481
- Acronym / sponsor ID
- 20221201
- Conditions
- Circadian Rhythm Disorders, Intestinal Flora
- Keywords
- Circadian rhythm, Gut microbiota, Metabolomics, Metagenomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Jan 2023 (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.
An observational clinical study on the changes of intestinal flora between people with circadian rhythm disorders and healthy controls was conducted to explore the relationship between circadian rhythm disorders and human intestinal microorganisms. To reveal the effects of circadian rhythm disorder on human intestinal microorganisms and metabolism on other potential diseases. In this study, 40 people with circadian disorders and 40 healthy controls were recruited. During the study, blood, urine and fecal samples of the subjects were obtained once, and the obtained biological samples were tested and analyzed by serum, urine metabolomics and fecal metagenomics. Subjects were also evaluated on the following scales : Circadian Type Inventory（CTI ）. The Epworth Sleeping Scale ( ESS ), Fatigue Scale-14 ( FS-14 ), Maslach Burnout Inventory-General Survey ( MBI-GS ), Athens Insomnia Scale ( AIS ), Insomnia Severity Index ( ISI ), Pittsburgh sleep quality index ( PSQI ), Bristol Stool Scale, Gastrointestinal Symptom Rating Scale ( GSRS ), Connor-Davidson resi.
Detailed description
This study will explore the relationship between circadian rhythm disorders and human intestinal flora. The subjects were included in strict accordance with the inclusion criteria. Feces, blood, urine or other biological samples were collected and analyzed. The clinical data assessment scale and biological samples of the subjects were collected only once.
- Data management The case report form ( CRF ) is a way of recording clinical data in clinical trials. The researchers should record all the relevant data of each subject in the experiment in a timely and true manner, and make confirmation and signature. CRF should not be changed at will. Researchers should sign and indicate the date when they do need to change. After the end of the trial, CRF was preserved by the clinical trial institution and sponsor of the researcher 's hospital. The completed CRF is reviewed by the clinical inspector and data entry is performed without modification. In order to ensure the privacy of subjects, the names of subjects on CRF need to use codes.
- Statistical analysis The statistical analysis plan should be formulated after the finalization of the plan and finalized before the database is locked. The statistical analysis plan will specify and describe all the statistical analysis contents according to the main characteristics of the plan.
- Preservation of data All clinical data and data analysis were recorded and managed by researchers.
- Ethics Committee : Ethics Committee of Army Characteristic Medical Center of PLA. Application procedure : fill in the application form of ethical approval and attach the relevant approval materials.
- Informed consent : The investigator must explain to each participant the nature, purpose, procedure, expected time, potential risks and benefits, and any discomfort that may arise, of the trial. Each subject must know that participation in the trial is voluntary and that he / she can withdraw from the trial at any time and withdraw his / her informed consent without affecting his / her subsequent treatment or relationship with the treating hysician. After explaining the basic content of the test and the researchers have been convinced that each participant will understand the purpose of the test, each participant should be required to sign the name and date on the informed consent form. Subjects should read and consider their tatements before signing and dated, and should obtain a copy of the informed consent form after signing. Subjects could not enter the trial without informed consent and without signed informed consent.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circadian rhythm disorders | – | –Observational, no intervention administered. |
| Healthy controls | – | –Observational, no intervention administered. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects of the study will recruit employees with certain regularity who are engaged in night or day shifts from Daping Hospital of Army Medical University.
Key inclusion criteria (5 listed)
- All genders, Age18~75,
- Regular night shift or day shift,
- No antibiotics and probiotics within one month,
- Possess understanding and communicate ability；no severe disease，no mental disorders,
- Fully informed consent, willing to participate in this study.
Key exclusion criteria (8 listed)
- Not willing to participate in this study,
- Patients with severe cognitive impairment or mental illness,
- Alcohol and drug dependence,
- The sleep disorder by alcohol and Coffee and/or Strong tea,
- No other Tranquilizers treatment was received within 1 week before the drug was used in this clinical trial,
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
Change of gut microbiota
Time frame: Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Alpha and Beta diversity of gut microbiota by metagenome. function and sequence-based analysis of gut microbiota microbial genome. The differential flora was obtained through differential analysis, and the correlation analysis was carried out between the differential flora and the differential metabolites. The difference in gut microbiota between people with circadian rhythm disorder and health controls is understood through stool detection.
10 secondary outcomes
Changes in metabolites of gut microbiota
Time frame: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Changes of serum metabolites
Time frame: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Changes of urine metabolites
Time frame: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Circadian Type Inventory
Time frame: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
The Epworth Sleeping Scale（ESS）
Time frame: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Fatigue Scale-14（FS-14）
Time frame: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Maslach Burnout Inventory-General Survey（MBI-GS）
Time frame: Only once.The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Athens Insomnia Scale（AIS）
Time frame: Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
The Depression Anxiety Stress Scale (DASS)
Time frame: Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
Related trials for Circadian Rhythm Disorders
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Body Clocks - Coordination of Peripheral and Central Oscillators
Circadian Dysregulation
Recruiting
NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment
Sleep Disorder, Circadian Dysregulation
Not yet recruiting
Effects of Taurine Supplementation and Morning or Evening High-intensity Exercise on Circadian Clock Genes and Inflammatory Parameters in Adult Women With Obesity
Obesity (Disorder), Inflammation
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
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. This study is not recruiting at the moment.
Yanling Wei*, MD principal investigator
Daping Hospital, Army Medical University
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 Circadian Rhythm Disorders and Intestinal Flora, run by Third Military Medical University 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanling Wei, MD (+8615310354666, lingzi016@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of gut microbiota (time frame: Only once. The experimental group shall fill in immediately after the end of the night shift and the control group shall fill in during work. (8:00 until 12:00)). 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 23 Jan 2023.