Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

NCT ID: NCT06013410

Last Updated: 2023-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2026-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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IBS group

patients diagnosed with IBS according to clinical presentations

Group Type EXPERIMENTAL

colonoscopy

Intervention Type DIAGNOSTIC_TEST

colonoscopy

Healthy control group

healthy control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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colonoscopy

colonoscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jinhua Hospital

UNKNOWN

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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2ndAffiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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WEI WEI

Role: CONTACT

15267175186

Facility Contacts

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WEI WEI

Role: primary

Other Identifiers

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2023-0381

Identifier Type: -

Identifier Source: org_study_id

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