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

NCT05311293 | Unknown

• 1 other identifier: irritable bowel syndrome
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (1)

• Anxiety and Depression Score

  To evaluate the extent to which a disease affects a mental condition

  up to 100 weeks

Study Arms (3)

Patients with simple diarrhea-predominant irritable bowel syndrome

Diagnostic Test: Endoscopy

Patients with irritable bowel syndrome accompanied by anxiety and depression

Diagnostic Test: Endoscopy

Healthy Volunteers

Diagnostic Test: Endoscopy

Interventions

Endoscopy DIAGNOSTIC_TEST

Observe the extent of colonic lesions and obtain intestinal mucosal samples

Healthy Volunteers; Patients with irritable bowel syndrome accompanied by anxiety and depression; Patients with simple diarrhea-predominant irritable bowel syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.;
• \. Patients who have taken drugs with bleeding risk or increased bleeding risk before treatment;
• \. Patients who have taken antidepressant drugs and psychotropic drugs before treatment;
• \. 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tang-Du Hospital

Xi'an, 712000, China

Location

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 5, 2022
• Study Start: November 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

CN (1)