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Clinical study on the application of magnetic-controlled sampling capsule endoscopy to digestive fluid sampling in patients with digestive diseases

Clinical study on the application of magnetic-controlled sampling capsule endoscopy to digestive fluid sampling in patients with digestive diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093558
Enrollment
Unknown
Registered
2024-12-06
Start date
2024-12-07
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Digestive tract disease

Interventions

Experimental group (Collection and Bioinformatics Analysis of Digestive Fluid and Fecal Samples from IBD and colorectal cancer patients):None
Control group (Collection and Bioinformatics Analysis of Digestive Fluid and Fecal Samples from Healthy Subjects):None

Sponsors

Wuhan Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 18-60 years old; 2. Patients diagnosed with IBD, colorectal cancer, or healthy individuals with normal endoscopic screening results, confirmed through imaging, endoscopy, and histopathological examinations; 3. Good compliance, able to cooperate and complete the entire clinical trial (routine endoscopy, imaging, and life-style examinations) as well as subsequent follow-ups; 4. Able to understand and accept the research protocol, voluntarily signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of alcohol consumption within the past 2 weeks or smoking within the past 6 months; 2. History of taking live bacterial preparations within the past 3 months or using antibiotics within the past 6 months; 3. Known or suspected gastrointestinal obstruction, stenosis, or fistula; 4. Presence of concomitant diseases that can alter the gastrointestinal microbiome (such as malabsorption syndrome); 5. Patients who have undergone extensive colectomy, resection of =3 segments of the small intestine, short bowel syndrome, ileostomy or colostomy, or those requiring long-term nasogastric feeding; 6. Severe infections (such as severe hepatitis, tuberculosis, pneumonia, and urinary tract infections) or other life-threatening diseases; 7. Immune dysfunction caused by genetic diseases or other conditions; 8. Pregnant or lactating women; 9. Inability to swallow the sampling capsule endoscope; 10. Patients with implanted cardiac pacemakers or other implanted electronic medical devices; 11. Patients with implanted metal parts that may be magnetized; 12. Patients with a scheduled MRI examination within 1 week after swallowing the capsule endoscope; 13. Concurrent participation in another clinical trial of drugs or devices; 14. Voluntary withdrawal from the study; 15. Inability to assume legal responsibility or those whose participation in the study is hindered by medical or ethical reasons; 16. Other conditions deemed unsuitable for this study by the investigators.

Design outcomes

Primary

MeasureTime frame
Digestive fluid intestinal flora, metabolites;

Secondary

MeasureTime frame
Fecal intestinal flora, metabolites;

Countries

China

Contacts

Public ContactRong Lin

Wuhan Union Hospital

wangweijunct@sina.com+86 135 4534 0998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026