Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Diagnostic Test: colonoscopy

• Registration Number: NCT06013410
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-12
• Study Start: 2023-08-25
• Study First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Primary Completion: 2026-05-10
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBS group	colonoscopy	patients diagnosed with IBS according to clinical presentations

Primary Outcome Measures

Name	Time	Method
mirobiome difference of the fecal between IBS and health controls	Fecal samples will be collected 7 days after the colonoscopy test (T2)	16S rDNA sequencing will be applied in fecal samples all the above participants
Metabolic changes between IBS and Healthy controls	1 day biopsy will be collected during the colonoscopy test	mucosal biopsy will be collected during the colonoscopy in each patients

Trial Locations

Locations (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China