Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— IBS  

Official title:

Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013410
• Other study ID #: 2023-0381
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: May 15, 2026

Study information

• Verified date: June 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: WEI WEI
• Phone: 15267175186
• Email: wwze[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 15, 2026
• Est. primary completion date: May 10, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• colonoscopy
colonoscopy

Locations

Country	Name	City	State
China	2ndAffiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Jinhua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mirobiome difference of the fecal between IBS and health controls	16S rDNA sequencing will be applied in fecal samples all the above participants	Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)
Primary	mirobiome difference of the fecal between IBS and health controls	16S rDNA sequencing will be applied in fecal samples all the above participants	Fecal samples will be collected 7 days after the colonoscopy test (T2)
Primary	Metabolic changes between IBS and Healthy controls	mucosal biopsy will be collected during the colonoscopy in each patients	1 day biopsy will be collected during the colonoscopy test