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 | Not Yet Recruiting

• 2 other identifiers: SCE-IBD82400777
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Sampling Capsule Endoscopy; Gut Microbiota; Crohn's disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Microbiota Analysis

  Studying the gut microbiota of patients diagnosed with inflammatory bowel disease to identify microorganism factors that induce disease, predictive biomarkers of the active and remission stages, and predictors of clinical prognosis.

  within 3 months after sampling

Secondary Outcomes (6)

• Metabolism Analysis

  within 3 months after sampling.

• The feasibility of the sampling capsule endoscopy system in collecting fluids from different intestinal segments in patients with IBD

  within 3 months after sampling.

• Sampling time

  within 3 months after sampling

• Sampling volume

  within 3 months after sampling

• Number of sampling times

  within 3 months after sampling

Study Arms (5)

Healthy Controls

Healthy volunteers without inflammatory bowel disease will be enrolled as the reference cohort for comparison with Crohn's disease and ulcerative colitis cohorts.

Remission-stage Crohn's disease patients

Participants with remission-stage Crohn's disease will be enrolled as the main longitudinal cohort. This cohort will provide saliva , stool ,Intestinal fluid, and the collected samples will be analyzed using advanced tests (16S rRNA sequencing, metagenomic sequencing, and metabolomics).

Active-stage Crohn's disease

Participants with active-stage Crohn's disease will be enrolled as the main longitudinal cohort. This cohort will provide saliva , stool ,Intestinal fluid, and the collected samples will be analyzed using advanced tests (16S rRNA sequencing, metagenomic sequencing, and metabolomics).

Remission-stage ulcerative colitis patients

Participants with remission-stage ulcerative colitis patients will be enrolled as the main longitudinal cohort. This cohort will provide saliva , stool ,Intestinal fluid, and the collected samples will be analyzed using advanced tests (16S rRNA sequencing, metagenomic sequencing, and metabolomics).

Active-stage ulcerative colitis

Participants with active-stage ulcerative colitis will be enrolled as the main longitudinal cohort. This cohort will provide saliva , stool ,Intestinal fluid, and the collected samples will be analyzed using advanced tests (16S rRNA sequencing, metagenomic sequencing, and metabolomics).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from healthy volunteers and patients receiving care at the study hospital (Changhai Hospital). The study population will include five groups: healthy controls, patients with active Crohn's disease, patients with Crohn's disease in remission, patients with active ulcerative colitis, and patients with ulcerative colitis in remission.Patients with inflammatory bowel disease (IBD) will be identified through outpatient clinics, inpatient wards, and routine clinical evaluation. Participants will be recruited using a non-probability sampling approach from outpatient clinics, inpatient wards, and healthy volunteer sources at Changhai Hospital.

You may qualify if:

• Male or female, aged 18 years or older and 80 years or younger;
• Willing and able to complete the study assessments, including repeated capsule endoscopy examinations and daily records of diet, activity, and defecation;
• Willing to provide fecal (stool), saliva, and intestinal fluid samples and to consent to long-term storage of the provided samples for research purposes;
• Willing to avoid vigorous physical activity during participation in this clinical trial;
• Willing to participate in this clinical trial and to sign the informed consent form.
• Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months during the screening period (Day -14 to 0), confirmed by endoscopic and histological evidence, with a histopathology report (if no report is available, endoscopy and histological examination may be performed at screening);
• No chronic gastrointestinal symptoms (e.g., abdominal pain, diarrhea, constipation, hematochezia, bloating);
• No history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, or other chronic gastrointestinal disorders;
• A normal colonoscopy within the past year, or a negative fecal occult blood test with no related symptoms if colonoscopy has not been performed.
• If any of the above items is answered "No", the subject cannot enter the study.

You may not qualify if:

• Other gastrointestinal diseases, including gastrointestinal cancer, indeterminate colitis, infectious colitis or colitis with a definite etiology, and toxic megacolon (for the UC cohort, Crohn's disease is also excluded; for the CD cohort, ulcerative colitis is also excluded);
• Known or suspected gastrointestinal obstruction, stricture, diverticulum, fistula, or perforation;
• Severe cardiac, pulmonary, or renal insufficiency, liver cirrhosis, hepatic insufficiency, or hematologic diseases;
• Known or suspected malignant tumors, acute severe illness, or other end-stage diseases, or concomitant diseases with an expected survival of less than 12 months;
• Any active infection caused by bacteria, viruses, fungi, or other pathogens, or recurrent or chronic infection;
• Receipt of anti-infective treatment (including antibacterial, antifungal, or antiviral agents) within 3 months before enrollment;
• Other medications (to be specified);
• Inability to undergo or refusal to undergo any abdominal surgery (capsule retention cannot be surgically managed);
• Planned magnetic resonance imaging (MRI) before the capsule endoscope is excreted;
• Dysphagia;
• Pregnant or lactating women;
• Poor general condition and inability to tolerate sampling capsule endoscopy;
• Any form of active substance abuse or dependence (including drug or alcohol abuse), any unstable physical or mental illness, or any chronic condition that the investigator considers may interfere with the conduct of the study;
• Participation in another clinical trial within three months, or current participation in another clinical trial;
• Any other factors that the investigator considers unsuitable for enrollment or that may affect the participant's participation in the study.

Sponsors & Collaborators

• Changhai Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples, feces samples,and Intestinal fluid will be collected and retained. The collected samples will be analyzed using advanced tests (16S rRNA sequencing, metagenomic sequencing, and metabolomics).

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Zhuan Liao, PhD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao, PhD

CONTACT

021-31162770; zhuanleo@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months after publication of the main study results and available for 5 years.
• Access Criteria: Researchers with a scientifically sound proposal may submit a data access request to the study investigators or the designated data management platform. Requests will be reviewed for scientific purpose, ethical approval, data security, and consistency with the informed consent and institutional policies. Data will be shared only after approval and, when required, completion of a data use agreement.