Irritable Bowel Syndrome Clinical Trial
— IBSOfficial title:
Pathophysiological Effects of Persistently Colonized Microbiome on Irritable Bowel Syndrome
NCT number | NCT06013410 |
Other study ID # | 2023-0381 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 25, 2023 |
Est. completion date | May 15, 2026 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 15, 2026 |
Est. primary completion date | May 10, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
China | 2ndAffiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | Jinhua Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 |
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