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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05043818
Enrollment
178
Registered
2021-09-14
Start date
2021-09-30
Completion date
2022-09-30
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

Ulcerative Colitis, Crohn's Disease,Anxiety , Depression

Brief 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.

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.

Interventions

None listed

Sponsors

Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PHQ-9 score0 weekPatient 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.

Secondary

MeasureTime frameDescription
SDS score0 weekSelf-rating Depression Scale. The score varies from 25 to 100. Higher scores suggest more severe depression.
HAMA-score0 weekHamilton 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.
HAMD-score0 weekHamilton 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.
HADS-score0 weekHospital 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.
Simplified CDAI score0 weekSimplified 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.
Modified Mayo score for UC0 weekModified 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.
IBD-QoL0 weekQuality 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.
GSRS-score0 weekGastrointestinal Symptom Rating Scale. The score varies from 16 to 112. High scores suggest more severe Gastrointestinal pathology.

Other

MeasureTime frameDescription
Intestinal flora0 weekUse metagenomics technology to detect intestinal flora.

Countries

China

Contacts

Primary ContactYanling Wei, MD
Lingzi016@126.com15310354666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026