Status:
NOT_YET_RECRUITING
Analysis of Differences in Small Intestinal Microbiota Structure and Metabolites Between Patients With Irritable Bowel Syndrome and Healthy Individuals
Lead Sponsor:
Zhongshan Hospital Xiamen University
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
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, pa...
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 composit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07212569
Start Date
October 1 2025
End Date
December 1 2028
Last Update
October 8 2025
Active Locations (1)
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1
Hongzhi Xu
Xiamen, Fujian, China