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

NCT05043818 | Unknown DMC

• 1 other identifier: TMMU-DP-GI-IBD
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Ulcerative Colitis, Crohn's Disease，Anxiety ， Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• SDS score

  0 week

• HAMA-score

  0 week

• HAMD-score

  0 week

• HADS-score

  0 week

• GSRS-score

  0 week

Other Outcomes (1)

• Intestinal flora

  0 week

Study Arms (2)

IBD patients with depression

IBD patients with depression

IBD patients without depression

IBD patients without depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Department of Gastroenterology, Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Yanling Wei, MD

  Army Medical Center of PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanling Wei, MD

CONTACT

15310354666; Lingzi016@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yanling Wei Deputy Chief Physician

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 14, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

CN (1)