Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome (IBS)

Zhejiang University

Status: Enrolling

Conditions: Irritable Bowel Syndrome

Treatments: Diagnostic Test: colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06013410

2023-0381

Details and patient eligibility

About

The goal of this clinical trial is to explore the pathophysiological effects of the persistently colonized microbiome in irritable bowel syndrome (IBS) patients. The main questions it aims to answer are:

Question 1: the microbiome difference of the biofilm between IBS and healthy patients.

Question 2: the metabolic product patterns between IBS and healthy patients.

Participants will need to take a colonoscopy examination, two gut mucosal biopsy samples will be collected during the examination.

Researchers will compare the IBS and healthy control groups to see if there was the disease-specific pattern in the microbiome and metabolic product of the biofilm.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• IBS patients with IV type; no abdominal surgery;

Exclusion criteria

• age <18 y;
• major disease;
• alcoholic addicted;
• antibiotic use in past 3 months;
• severe gastrointestinal disease
• severe cardiac disease;
• pregnant;
• ICU in past 1 year;
• vegeterian;
• immune disease (SLE etc.)
• mental disease;

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

IBS group

Experimental group

Description:

patients diagnosed with IBS according to clinical presentations

Treatment:

Diagnostic Test: colonoscopy

Healthy control group

No Intervention group

Description:

healthy control group