Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07212569
Enrollment
90
Registered
2025-10-08
Start date
2025-10-01
Completion date
2028-12-01
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, small intestinal microbiota

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.

Interventions

None listed

Sponsors

Zhongshan Hospital Xiamen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Identify the specific differences in the core architecture of the small intestinal microbiota between IBS patients and healthy individuals.6 MonthsIntestinal 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.

Countries

China

Contacts

Primary ContactHongzhi Xu Doctor
Xuhongzhi07@163.com13606000360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026