Analysis of Differences in Small Intestinal Microbiota Structure and Metabolites Between Patients With Irritable Bowel Syndrome and Healthy Individuals

Not yet recruiting

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT07212569
• Lead Sponsor: Zhongshan Hospital Xiamen University

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 Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-01
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2028-10-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Experimental Group： Aged 18-65 years, male or female. Meets the Rome IV diagnostic criteria for IBS The absence of organic gastrointestinal disease that could explain the symptoms.

Provides informed consent and voluntarily signs the informed consent form. Control Group： Age and sex-matched to the IBS patient group. No history of chronic digestive diseases or current gastrointestinal symptoms. Has not used antibiotics, proton pump inhibitors, probiotics, or other medications known to affect gut microbiota within the past month.

Provides informed consent and voluntarily signs the informed consent form.

Exclusion Criteria

History of gastrointestinal surgery (excluding appendectomy). Presence of concomitant organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, gastrointestinal tumors).

Presence of severe concomitant cardiac, hepatic, renal, endocrine, hematologic, or neurological diseases.

Long-term use of medications known to affect gastrointestinal motility (e.g., opioids).

Pregnancy, lactation, or women planning a pregnancy. Conditions contraindicating the use of capsule endoscopy, such as dysphagia, or known gastrointestinal strictures, diverticula, or obstruction.

Any other condition deemed by the investigator as unsuitable for participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify the specific differences in the core architecture of the small intestinal microbiota between IBS patients and healthy individuals.	6 Months	Intestinal content samples from different regions were collected from IBS patients and healthy subjects using smart enteric-coated sampling capsules. These samples subsequently underwent 16S rRNA gene sequencing and metagenomic sequencing to analyze microbial composition, alongside untargeted metabolomics to detect metabolic differences. The regional variations in both the microbiome and metabolome were then analyzed in the IBS cohort.

Trial Locations

Locations (1)

Hongzhi Xu; 🇨🇳 Xiamen, Fujian, China