Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:

Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05311293
• Other study ID #: irritable bowel syndrome
• Status: Enrolling by invitation
• Start date: November 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, collecting peripheral blood for proteomic analysis, the two groups and patient symptoms are associated, and then discover the characteristics of molecular level changes associated with brain-gut axis dysfunction, explore the pathophysiological mechanism of comorbid anxiety and depression and IBS, and discover potential targets for effective treatment. This project can help to construct the colonic single-cell map of IBS-D patients and explore the differentially expressed genes in the colon of IBS patients and their signaling pathways related to neuroregulation, providing an effective therapeutic target for the treatment of comorbid anxiety and depression and IBS.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome;

2. Aged between 18 and 65 years old (inclusive), male or female;

3. HAMA assessment = 14 points or HAMD assessment = 17 points

Exclusion Criteria:

1. Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, coronary heart disease, etc.);

2. 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;

3. Patients with a history of abdominal surgery (except appendectomy and cholecystectomy);

4. 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.;

5. 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;

6. Previous diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis;

7. Previous diagnosis of diseases affecting the digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.;

8. 4. Patients who have taken drugs with bleeding risk or increased bleeding risk before treatment;

9. 4. Patients who have taken antidepressant drugs and psychotropic drugs before treatment;

10. 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;

11. Allergic constitution;

12. Pregnant and lactating women; Others that may affect study compliance or adversely affect the results as judged by the investigator.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Diagnostic Test:
• Endoscopy
Observe the extent of colonic lesions and obtain intestinal mucosal samples

Locations

Country	Name	City	State
China	Tang-Du Hospital	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and Depression Score	To evaluate the extent to which a disease affects a mental condition	up to 100 weeks