Back to resultsPathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome (IBS)
Primary Purpose
Irritable Bowel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Irritable Bowel Syndrome
Eligibility Criteria
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;
Sites / Locations
- 2ndAffiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
IBS group
Healthy control group
Arm Description
patients diagnosed with IBS according to clinical presentations
healthy control group
Outcomes
Primary Outcome Measures
mirobiome difference of the fecal between IBS and health controls
16S rDNA sequencing will be applied in fecal samples all the above participants
mirobiome difference of the fecal between IBS and health controls
16S rDNA sequencing will be applied in fecal samples all the above participants
Metabolic changes between IBS and Healthy controls
mucosal biopsy will be collected during the colonoscopy in each patients
Secondary Outcome Measures
Full Information
NCT ID
NCT06013410
First Posted
June 12, 2023
Last Updated
August 25, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jinhua Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06013410
Brief Title
Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome
Acronym
IBS
Official Title
Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Anticipated)
Primary Completion Date
May 10, 2026 (Anticipated)
Study Completion Date
May 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jinhua Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IBS group
Arm Type
Experimental
Arm Description
patients diagnosed with IBS according to clinical presentations
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
healthy control group
Intervention Type
Diagnostic Test
Intervention Name(s)
colonoscopy
Intervention Description
colonoscopy
Primary Outcome Measure Information:
Title
mirobiome difference of the fecal between IBS and health controls
Description
16S rDNA sequencing will be applied in fecal samples all the above participants
Time Frame
Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)
Title
mirobiome difference of the fecal between IBS and health controls
Description
16S rDNA sequencing will be applied in fecal samples all the above participants
Time Frame
Fecal samples will be collected 7 days after the colonoscopy test (T2)
Title
Metabolic changes between IBS and Healthy controls
Description
mucosal biopsy will be collected during the colonoscopy in each patients
Time Frame
1 day biopsy will be collected during the colonoscopy test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WEI WEI
Phone
15267175186
Email
wwze@zju.edu.cn
Facility Information:
Facility Name
2ndAffiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WEI WEI
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
share on request
Learn more about this trial
Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome
We'll reach out to this number within 24 hrs