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A multicenter clinical study of Nano-LAMP-microfluidic microarray technology for the detection of a panel of blood and fecal markers to aid in the diagnosis of inflammatory bowel disease

A multicenter clinical study of Nano-LAMP-microfluidic microarray technology for the detection of a panel of blood and fecal markers to aid in the diagnosis of inflammatory bowel disease

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107219
Enrollment
Unknown
Registered
2025-08-06
Start date
2025-02-10
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

Inflammatory bowel disease

Interventions

Gold Standard:Diagnosis of IBD (Ulcerative Colitis and Crohn's Disease) requires comprehensive analysis combining clinical manifestations, laboratory tests, endoscopic examination, imaging studies, an
anemia (possible iron/B12 deficiency in CD)
leukocytosis. - Stool tests: Elevated calprotectin/lactoferrin (inflammatory markers), exclusion of infections (e.g., C. difficile). - Serological tests (auxiliary): p-ANCA (more common in UC), ASCA (
pelvic MRI or endoscopic ultrasound (EUS) for perianal lesions. 5. Histopathological Features: - UC: Crypt abscesses, superficial inflammation (mucosa/submucosa), basal plasmacytosis. - CD: Transmural
Index test:Method: Nano-LAMP-microfluidic chip technology Blood tests: Complete blood count, serum albumin, electrolytes, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) Stool tests:

Sponsors

Shanghai Science and Technology Commission
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria for UC/CD in Western medicine; 2. Patients with polyps diagnosed by colonoscopy and resected; 3. No other underlying diseases; 4. No history of long-term medication for other chronic diseases; 5. Patients who meet the diagnostic criteria for other diseases of the intestinal tract in Western medicine, including intestinal polyps, colorectal cancer, chronic inflammatory bowel disease, irritable bowel syndrome, and other intestinal disorders; 6. Patients who have signed an informed consent form; 7. Age Between 18-80 years old.

Exclusion criteria

Exclusion criteria: 1. Co-existing with other immune system diseases, such as immune hepatitis, connective tissue disease, systemic lupus erythematosus, scleroderma, etc.; 2. History of long-term drug taking due to other diseases, such as gastric ulcer, duodenal ulcer, chronic gastritis, intestinal tuberculosis, tuberculous peritonitis, chronic diarrhea, chronic pancreatitis, etc.; 3. Co-infected with infectious diseases such as AIDS, hepatitis B, tuberculosis, etc.; 4. During pregnancy, Lactating women; 5. Patients who are unable to complete the short-term dietary questionnaire due to mental and intellectual factors; 6. Patients who have participated in other oral drug clinical trials in the last 1-3 months; 7. Patients who are unwilling to accept return visits and continuous testing; 8. Patients who are younger than 18 years old or older than 80 years old.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;repeatability;limit of detection;

Countries

China

Contacts

Public ContactWeiwei Liu

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

huashanvivian@126.com+86 131 6264 0870

Outcome results

None listed

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