Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT07212569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Differences in Small Intestinal Microbiota Structure and Metabolites Between Patients With Irritable Bowel Syndrome and Healthy Individuals
Sponsor:
Zhongshan Hospital Xiamen University
Organization:
Study Overview
Official Title:
Analysis of Differences in Small Intestinal Microbiota Structure and Metabolites Between Patients With Irritable Bowel Syndrome and Healthy Individuals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Irritable Bowel Syndrome (IBS) is a common functional bowel disorder with complex and not yet fully elucidated pathophysiological mechanisms. Recent research suggests that gut microbiota dysbiosis, particularly small intestinal bacterial overgrowth (SIBO), may play a key role in the generation of IBS symptoms. However, the vast majority of current studies have focused on fecal samples, which primarily reflect the colonic microbiota. The small intestinal microbiota, which is directly involved in nutrient digestion and absorption and more prone to dysbiosis, remains understudied due to the challenges in obtaining samples.
Detailed Description:
This study aims to utilize intestinal sampling capsules to directly collect small intestinal fluid samples from both IBS patients and healthy controls. The community structure, diversity, and compositional differences of the small intestinal microbiota will be analyzed using 16S rRNA gene sequencing and metagenomic sequencing technologies, while the metabolic profiles of the small intestinal fluid will be detected via untargeted metabolomics.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: