Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome (IBS)

August 25, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • 2ndAffiliated Hospital, School of Medicine, Zhejiang University
        • Contact:
          • Wei Wei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mirobiome difference of the fecal between IBS and health controls
Time Frame: 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
Fecal samples will be collected immediately before the colonoscopy (T1) and 7 days after the colonoscopy test (T2)
mirobiome difference of the fecal between IBS and health controls
Time Frame: 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
Fecal samples will be collected 7 days after the colonoscopy test (T2)
Metabolic changes between IBS and Healthy controls
Time Frame: 1 day biopsy will be collected during the colonoscopy test
mucosal biopsy will be collected during the colonoscopy in each patients
1 day biopsy will be collected during the colonoscopy test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Jinhua Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 25, 2023

Primary Completion (Estimated)

May 10, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

share on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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