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Clinical Trials in China / NCT07212569
Starting soon Observational

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

NCT07212569 · tracked via the Priya Life Science China tracker
Sponsor
Zhongshan Hospital Xiamen University
Phase
Observational
Started
2025-10-01
Last updated
2025-10-08

Condition(s) studied

Irritable Bowel Syndrome

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Hongzhi Xu Xiamen Fujian

More Zhongshan Hospital Xiamen University trials in China

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Other trials for the same condition

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Recruiting
Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome Recruiting
Efficacy of Probiotics in Patients With IBD Recruiting
Efficacy of Esketamine for Patients With Irritable Bowel Syndrome Recruiting
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07212569 on ClinicalTrials.gov ↗ ← All trials in China