Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

NCT06013410 | Recruiting DMC

• 1 other identifier: 2023-0381
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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

Study Arms (2)

IBS group

EXPERIMENTAL

patients diagnosed with IBS according to clinical presentations

Diagnostic Test: colonoscopy

Healthy control group

NO INTERVENTION

healthy control group

Interventions

colonoscopy DIAGNOSTIC_TEST

colonoscopy

IBS group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• IBS patients with IV type; no abdominal surgery;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Jinhua Hospital: collaborator

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

WEI WEI

CONTACT

15267175186; wwze@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: August 28, 2023
• Study Start: August 25, 2023
• Primary Completion: May 10, 2026
• Study Completion: May 15, 2026
• Last Updated: August 28, 2023

Record last verified: 2023-06

Locations

CN (1)