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

January 12, 2023 updated by: Yanling Wei, Third Military Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Department of Gastroenterology, Daping Hospital, The Third Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Circadian rhythm disorders
Observational, no intervention administered.
Healthy controls
Observational, no intervention administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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.
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)
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.
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 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.
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)
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.
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)
Evaluate the severity of people's fatigue. The total score is 14 points. The higher the score, the more fatigue.
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)
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.
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 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.
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Third Military Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yanling Wei*, MD, Daping Hospital, Army Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20221201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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