An Observational Clinical Study on the Intestinal Flora in Circadian Rhythm Disorder and Healthy Controls

NCT05694481 | Unknown

• 1 other identifier: 20221201
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Rhythm Disorders; Intestinal Flora

Keywords

Circadian rhythm; Gut microbiota; Metabolomics; Metagenomes

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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)

  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)

Study Arms (2)

Circadian rhythm disorders

Observational, no intervention administered.

Healthy controls

Observational, no intervention administered.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Department of Gastroenterology, Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, feces, urine Serum refers to the light yellow transparent liquid separated from plasma by removing fibrinogen after blood coagulation. Faecalis, refers to the excretion of human and animal. Urine, is a fluid like metabolite excreted from the human body.

MeSH Terms

Conditions

Chronobiology Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Yanling Wei*, MD

  Daping Hospital, Army medical university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanling Wei, MD

CONTACT

+8615310354666; lingzi016@tmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician / Associate professor

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 23, 2023
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

CN (1)