Irritable bowel Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed clinical diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) fulfilling the Rome IV criteria; 2. Comorbid anxiety and/or depression, defined as a baseline score of >=50 on the Self-Rating Anxiety Scale (SAS) and/or the Self-Rating Depression Scale (SDS) during routine admission assessments; 3. Recent colonoscopy (within the previous 12 months) demonstrating normal findings, although minor abnormalities such as hemorrhoids or <= 3 polyps with a maximum diameter <=5 mm were permitted.
Exclusion criteria
Exclusion criteria: 1. Severe organic gastrointestinal or peripheral digestive system diseases (e.g., tuberculous peritonitis, pancreatitis, liver cirrhosis, biliary tract diseases), lactose intolerance, celiac disease, or other severe systemic conditions (e.g., significant cardiovascular, hepatic, or renal dysfunction, malignancies, autoimmune diseases, and metabolic disorders); 2. Severe psychiatric disorders other than anxiety and depression; 3. MRI contraindications or intolerance (e.g., claustrophobia), or the presence of = 5 ischemic white matter lesions on brain MRI; 4. Incomplete clinical or neuroimaging data, or poor MRI image quality; 5. Pregnancy, lactation, or current plans to conceive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diffusion tensor image analysis along the perivascular space (ALPS) index ;Choroid Plexus Volume, CPV;White Matter Free-Water Volume Fraction, WM-FW;Perivascular Spaces Volume, PVS;Bristol Stool Scale, BBS;global blood-oxygen-level-dependent signal and cerebrospinal fluid inflow coupling, gBOLD-CSF; | — |
Secondary
| Measure | Time frame |
|---|---|
| Irritable Bowel Syndrome Symptom Severity Scale, IBS-SSS;Irritable Bowel Syndrome Quality of Life Questionnair, IBS-QOL;Self-Rating Anxiety Scale, SAS;Self-Rating Depression Scale, SDS;Numerical Rating Scale, NRS; | — |
Countries
China
Contacts
Shenzhen Hospital of Southern Medical University