Gut Microbiota in IBD With Comorbid Depressive Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFang Tang
About this trial
Inflammatory bowel disease (IBD) is often comorbid with depressive disorder, and the development and progression of both conditions are closely related to the composition of gut microbiota and metabolites. However, studies investigating their comorbidity using microbiome and metabolomics approaches remain limited.
This study aims to investigate the diversity changes in the gut microbiome and metabolome of patients with comorbid IBD and depressive disorder through multi-omics approaches, to identify specific microbial and metabolic signatures associated with the comorbidity of these two conditions, and to provide a molecular basis for elucidating the underlying mechanisms.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).
History of depressive disorder diagnosis or previous use of antidepressant medications.
Age ≥ 18 years.
Willingness to participate and provision of written informed consent.
Disqualifiers
Presence of other major chronic diseases or infections (e.g., malignancy, hypertension, diabetes, coronary heart disease).
Use of antibiotics or probiotic supplements within the past 6 months.
Inability or difficulty in providing biological samples.
Missing essential patient information.
Trial population
Patients with inflammatory bowel disease with or without comorbid depressive disorder, and control participants, recruited from the First Affiliated Hospital of Shandong First Medical University.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not applicable- observational study
Other interventionobservational study with no assigned intervention
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: IBD with Depressive Disorder Group1 intervention
Group B: IBD without Depressive Disorder Group1 intervention
Group C: Control Group1 intervention
Trial outcomes
Primary outcomes
1
Gut microbiota composition and relative abundance
The primary outcome is the expression level and diversity of gut microbial taxa identified through metagenomic analysis among the three study groups.
Time frame
BaselineSecondary outcomes
1
Metabolite profiles and relative abundance
The secondary outcome is the expression level and diversity of serum and fecal metabolites identified through untargeted metabolomics analysis, and their correlations with gut microbial composition.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fang Tang
Lead sponsor
Qianfoshan Hospital
Sponsor institution
Source ClinicalTrials.gov