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Accurately Profiling the Changes and Functions of Key Microflora in the Whole Intestinal Microenvironment Based on the Visual Sampling Capsule Endoscopy in Patients With Inflammatory Bowel Disease

NCT07799506 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-09-02

No results posted yet for this study

Summary

This is a prospective, single-center, observational cohort study that will enroll 250 participants: 50 with active Crohn's disease, 50 with Crohn's disease in remission, 50 with active ulcerative colitis, 50 with ulcerative colitis in remission, and 50 healthy volunteers. Using a novel visual sampling capsule endoscope, intestinal fluid will be collected non-invasively from four intestinal regions: the upper jejunum, the upper ileum, the terminal ileum, and the colon. Saliva and stool samples will also be collected. All samples will be analyzed using 16S rRNA sequencing, metagenomic sequencing, and non-targeted metabolomics. The study aims to characterize the distribution and function of gut microbiota and metabolites across different intestinal regions in patients with inflammatory bowel disease (IBD), to compare active-stage and remission-stage disease, and to compare IBD patients with healthy volunteers, while evaluating the feasibility and safety of the visual sampling capsule endoscope in IBD patients.

Conditions

  • Crohn's Disease (CD)
  • Ulcerative Colitis (UC)

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Zhuan Liao, PhD · Changhai Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2028-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07799506 on ClinicalTrials.gov