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

NCT07212569 | Not Yet Recruiting DMC

• 1 other identifier: xmzsyyky-2025-137
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; small intestinal microbiota

Outcome Measures

Primary Outcomes (1)

• Identify the specific differences in the core architecture of the small intestinal microbiota between IBS patients and healthy individuals.

  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.

  6 Months

Study Arms (2)

Experimental Group

All participants ingest an intestinal sampling capsule for small intestinal fluid collection. Upon capsule retrieval, the samples are analyzed for their microbial DNA and metabolite content.

Control Group

All participants ingest an intestinal sampling capsule for small intestinal fluid collection. Upon capsule retrieval, the samples are analyzed for their microbial DNA and metabolite content.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort included Rome IV-diagnosed IBS patients without confounding surgical or medication history, along with age- and sex-matched healthy controls.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Hongzhi Xu

Xiamen, Fujian, China

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Hongzhi Xu Doctor

CONTACT

13606000360; Xuhongzhi07@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)