Clinical trial NCT05694481: An Observational Clinical Study on the Intestinal Flora in Circadian Rhythm Disorder and Healthy Controls
Official title: Effect of Circadian Rhythm Disorder on Human Intestinal Microbiota
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circadian Rhythm Disorders
Intestinal Flora
Keywords: Circadian rhythm
Gut microbiota
Metabolomics
Metagenomes
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

1. 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.
2. 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.
3. Preservation of data All clinical data and data analysis were recorded and managed by researchers.
4. 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.
5. 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.

Eligibility criteria: Inclusion Criteria:

1. All genders, Age18\~75,
2. Regular night shift or day shift,
3. No antibiotics and probiotics within one month,
4. Possess understanding and communicate ability；no severe disease，no mental disorders,
5. Fully informed consent, willing to participate in this study.

Exclusion Criteria:

1. Not willing to participate in this study,
2. Patients with severe cognitive impairment or mental illness,
3. Alcohol and drug dependence,
4. The sleep disorder by alcohol and Coffee and/or Strong tea,
5. No other Tranquilizers treatment was received within 1 week before the drug was used in this clinical trial,
6. Severe intestinal infection, such as salmonella, shigella, pestis, etc,
7. Pregnant or lactating women,
8. Other reasons not suitable for clinical trial.

Primary outcomes:
measure: Change of gut microbiota
timeFrame: 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:
measure: Changes in metabolites of gut microbiota
timeFrame: 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)
measure: Changes of serum metabolites
timeFrame: 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)
measure: Changes of urine metabolites
timeFrame: 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)
measure: Circadian Type Inventory
timeFrame: 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)
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 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)
measure: The Epworth Sleeping Scale（ESS）
timeFrame: 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)
measure: Fatigue Scale-14（FS-14）
timeFrame: 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)
measure: Maslach Burnout Inventory-General Survey（MBI-GS）
timeFrame: 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)
measure: Athens Insomnia Scale（AIS）
timeFrame: 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)
measure: The Depression Anxiety Stress Scale (DASS)
timeFrame: 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)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Gastroenterology, Daping Hospital, The Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital, Army medical university
name: Yanling Wei*, MD
role: PRINCIPAL_INVESTIGATOR
References: