An observational study in Inflammatory Bowel Diseases, sponsored by Third Military Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by Third Military Medical University · Observational
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.
The subjects voluntarily participated in the study and signed an informed consent form. Follow the steps below:
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.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's planned enrollment of 178 is above the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Third Military Medical University is the lead sponsor of 81 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with inflammatory bowel disease diagnosed in the outpatient clinic or hospitalization of our hospital
Exclusion Criteria:
IBD patients with depression
IBD patients without depression
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.
Time frame: 0 week
SDS score
Self-rating Depression Scale. The score varies from 25 to 100. Higher scores suggest more severe depression.
Time frame: 0 week
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.
Time frame: 0 week
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.
Time frame: 0 week
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.
Time frame: 0 week
GSRS-score
Gastrointestinal Symptom Rating Scale. The score varies from 16 to 112. High scores suggest more severe Gastrointestinal pathology.
Time frame: 0 week
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.
Time frame: 0 week
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.
Time frame: 0 week
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.
Time frame: 0 week
Intestinal flora
Use metagenomics technology to detect intestinal flora.
Time frame: 0 week
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Third Military Medical University