Status:
UNKNOWN
Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis
Lead Sponsor:
Tang-Du Hospital
Conditions:
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18-65 years
Brief Summary
The research group intends to carry out a case-control study to recruit IBS-D patients with anxiety and depression symptoms, by collecting intestinal mucosa for single-cell transcriptome sequencing, c...
Eligibility Criteria
Inclusion
- Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
- Aged between 18 and 65 years old (inclusive), male or female;
- HAMA assessment ≥ 14 points or HAMD assessment ≥ 17 points
Exclusion
- Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, coronary heart disease, etc.);
- Abnormal liver and kidney function (ALT or AST \> 1.5 times the upper limit of normal, or T-Bil \> 1.5 times the upper limit of normal, or Cr more than the upper limit of normal), hematopoietic system diseases and tumors;
- Patients with a history of abdominal surgery (except appendectomy and cholecystectomy);
- Previous diagnosis of organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer, infectious diarrhea, etc.;
- Previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as eosinophilic enteritis, microscopic colitis (including collagen colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome;
- Previous diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis;
- Previous diagnosis of diseases affecting the digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.;
- 4\. Patients who have taken drugs with bleeding risk or increased bleeding risk before treatment;
- 4\. Patients who have taken antidepressant drugs and psychotropic drugs before treatment;
- 4\. Use drugs that affect gastrointestinal motility and function, such as prokinetic drugs, anticholinergic drugs, calcium channel blockers, 5-HT receptor agonists/antagonists, antidiarrheal agents, antacids, intestinal bacteria modulators and antibiotics;
- Allergic constitution;
- Pregnant and lactating women; Others that may affect study compliance or adversely affect the results as judged by the investigator.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05311293
Start Date
November 1 2021
End Date
December 1 2023
Last Update
April 5 2022
Active Locations (1)
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1
Tang-Du Hospital
Xi'an, China, 712000