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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05043818
• Other study ID #: TMMU-DP-GI-IBD
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Third Military Medical University
• Contact: Yanling Wei, MD
• Phone: 15310354666
• Email: Lingzi016[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Inflammatory Bowel Diseases

Locations

Country	Name	City	State
China	Department of Gastroenterology, Daping Hospital, The Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intestinal flora	Use metagenomics technology to detect intestinal flora.	0 week
Primary	PHQ-9 score	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	SDS score	Self-rating Depression Scale. The score varies from 25 to 100. Higher scores suggest more severe depression.	0 week
Secondary	HAMA-score	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
Secondary	HAMD-score	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
Secondary	HADS-score	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
Secondary	GSRS-score	Gastrointestinal Symptom Rating Scale. The score varies from 16 to 112. High scores suggest more severe Gastrointestinal pathology.	0 week
Secondary	Simplified CDAI score	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
Secondary	Modified Mayo score for UC	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
Secondary	IBD-QoL	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