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Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06013410
Acronym
IBS
Enrollment
30
Registered
2023-08-28
Start date
2023-08-25
Completion date
2026-05-15
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

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.

Interventions

DIAGNOSTIC_TESTcolonoscopy

colonoscopy

Sponsors

Jinhua Hospital
CollaboratorUNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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;

Design outcomes

Primary

MeasureTime frameDescription
mirobiome difference of the fecal between IBS and health controlsFecal 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
Metabolic changes between IBS and Healthy controls1 day biopsy will be collected during the colonoscopy testmucosal biopsy will be collected during the colonoscopy in each patients

Countries

China

Contacts

Primary ContactWEI WEI
wwze@zju.edu.cn15267175186

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026