IBS: Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06013410

Collaborator

Jinhua Hospital (Other)

Enrollment

Location

Arms

32.7

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Diagnostic Test: colonoscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

Anticipated Study Start Date :

Aug 25, 2023

Anticipated Primary Completion Date :

May 10, 2026

Anticipated Study Completion Date :

May 15, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBS group patients diagnosed with IBS according to clinical presentations	Diagnostic Test: colonoscopy colonoscopy
No Intervention: Healthy control group healthy control group

Arm

Intervention/Treatment

Experimental: IBS group

patients diagnosed with IBS according to clinical presentations

Diagnostic Test: colonoscopy

colonoscopy

No Intervention: Healthy control group

healthy control group

Outcome Measures

Primary Outcome Measures

mirobiome difference of the fecal between IBS and health controls [Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)]
16S rDNA sequencing will be applied in fecal samples all the above participants
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2ndAffiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
Jinhua Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT06013410

Other Study ID Numbers:

2023-0381

First Posted:

Aug 28, 2023

Last Update Posted:

Aug 28, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Syndrome

Study Results

No Results Posted as of Aug 28, 2023