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NCT05694481
An Observational Clinical Study on the Intestinal Flora in Circadian Rhythm Disorder and Healthy Controls
Conditions: Circadian Rhythm Disorders, Intestinal Flora
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: 1
Enrollment: 80
Sponsor: Third Military Medical University
Location: China
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.
Eligibility Criteria
Inclusion Criteria: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.Exclusion Criteria: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.
Source: ClinicalTrials.gov (NCT05694481). StuddyBuddy aggregates publicly available trial information.