A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression

September 6, 2021 updated by: Yanling Wei, Third Military Medical University
Inflammatory bowel disease (IBD) seriously affects the quality of life of patients. During treatment, it is found that patients are often accompanied by a certain degree of psychological problems, such as depression, sensitivity, introversion, depression, and pessimistic disappointment. Among them, anxiety and depression are the most common. Through prospective observational research, statistics of the incidence of depression in inflammatory bowel disease in our hospital, comparison of the proportions of each subtype, screening of intestinal biomarkers in IBD patients with depression, and observation of inflammatory bowel disease with different The type and quantity of different intestinal flora in patients with severe depression, and the correlation between intestinal flora and depression.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The subjects voluntarily participated in the study and signed an informed consent form. Follow the steps below:

  1. When you come to the hospital or the first to second days of admission, collect general information: ID number, gender, age, height, weight, BMI, complete medical history including a) date of diagnosis, b) degree of disease, c) course of disease , D) previous surgery, e) previous hospitalization, f) comorbidities, g) current symptoms, h) extra-articular manifestations, i) endoscopic data, j) treatment drugs and other data.
  2. Scale evaluation (see Annex 1 for details): Screening related scales for anxiety and depression symptoms (PHQ9, SDS, HADS, HAMA, HAMD), inflammatory bowel disease quality of life scale (IBDQ), ulcerative colitis Patient's modified Mayo score/Simplified questionnaire surveys for patients with Crohn's disease such as CDAI score, stool characteristics, abdominal pain degree, and Gastrointestinal Symptom Scale (GSRS);
  3. Stool specimens were collected once during the visit to the hospital.
  4. The time, frequency and precautions for patients to go to the hospital for examination and follow-up.

This trial is a prospective observational study. When the patient comes to the hospital or on the first to the second day of admission, the subject will be given a full set of scales to check once, and a stool sample will be collected during the treatment. Co., Ltd. performed 16S rRNA sequencing to analyze the results of the bacterial flora once. In this study, there is no need for patients to come to the hospital for follow-up follow-up.

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.
178

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:
        • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with inflammatory bowel disease diagnosed in the outpatient clinic or hospitalization of our hospital

Description

Inclusion Criteria:

  1. Definite diagnosis of inflammatory bowel disease【diagnostic criteria reference: (2020)JSGE Evidence-based clinical practice guidelines: inflammatory bowel disease】
  2. There is no restriction on men and women, aged 18-65 years old;
  3. No complicated other serious diseases such as heart, brain, lung, liver, kidney, etc., no mental illness, and normal communication skills;
  4. No antibiotics, Bifidobacterium, Bacillus subtilis and other probiotic preparations have been used within one month;
  5. Sign the informed consent form and agree to participate in this research.

Exclusion Criteria:

  1. Course of disease <6 months;
  2. Unspecified inflammatory bowel disease.
  3. Authors with bipolar disorder, persistent mood disorder, and mania;
  4. Patients with malignant tumors;
  5. Patients during pregnancy and lactation;
  6. Combined with hypertension, diabetes, heart disease, stroke or severe chronic disease (infectious, genetic, metabolic, internal Secretory diseases);
  7. Patients who cannot cooperate to complete the study.

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

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.
IBD patients with depression
IBD patients without depression

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
PHQ-9 score
Time Frame: 0 week

Patient Health Questionnaire-9. The score varies from 0 to 27, higher scores suggest more severe the depression.Total score is the sum of 9 corresponding numbers:

0-4 points: no depression; 5-9 points: mild depression; 10-14 points: moderate depression; 15-27 points: severe depression.
0 week

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
SDS score
Time Frame: 0 week
Self-rating Depression Scale. The score varies from 25 to 100. Higher scores suggest more severe depression.
0 week
HAMA-score
Time Frame: 0 week
Hamilton Anxiety Scale.The total score is 0-56, among which, physical anxiety: 7-13 items; mental anxiety: 1-6 and 14 items.The higher the score, the greater the anxiety.
0 week
HAMD-score
Time Frame: 0 week
Hamilton Depression Scale.The total score is 0-35 points: >35 points: severe depression; >20 points: mild or moderate depression; 8-20 may have depression; <8 points: no depression. The higher the score, the greater the anxiety.
0 week
HADS-score
Time Frame: 0 week
Hospital Anxiety and Depression Scale.It consists of 14 (7 anxiety and 7 depression-related) scoring items, all ranging from 0-21. The higher the score, the more severe the anxiety and depression.
0 week
GSRS-score
Time Frame: 0 week
Gastrointestinal Symptom Rating Scale. The score varies from 16 to 112. High scores suggest more severe Gastrointestinal pathology.
0 week
Simplified CDAI score
Time Frame: 0 week
Simplified CDAI score for Crohn's disease: represents disease activity, <4 remission period 5~8 moderate activity> 9 heavy activity. The higher the score, the more severe the condition.
0 week
Modified Mayo score for UC
Time Frame: 0 week
Modified Mayo score for ulcerative colitis: a total of 0-12 points, scores ≤ 2 points and no single sub-item score> 1 points to clinical remission, 3 to 5 points to mild activity, 6 to 10 points to moderate activity, 11 ~12 is divided into heavy activity.
0 week
IBD-QoL
Time Frame: 0 week
Quality of Life Analysis Table for Patients with Inflammatory Bowel Disease: There are 32 questions in total. Each question has a different level of answer from 1 to 7, 1 generation The table has the heaviest degree, and 7 represents the least degree.
0 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intestinal flora
Time Frame: 0 week
Use metagenomics technology to detect intestinal flora.
0 week

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, Army Medical Center of PLA

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.
September 1, 2021

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.
September 1, 2022

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.
September 1, 2022

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).
August 9, 2021

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.
September 6, 2021

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.
September 14, 2021

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.
September 14, 2021

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.
September 6, 2021

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.
September 1, 2021

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.
  • TMMU-DP-GI-IBD

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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