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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06013410
Other study ID # 2023-0381
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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