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Establishment of a diagnostic model for intestinal barrier injury based on metabolomic features

Establishment of a diagnostic model for intestinal barrier injury based on metabolomic features

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121187
Enrollment
Unknown
Registered
2026-03-26
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

intestinal barrier injury

Interventions

Gold Standard:Dual sugar test (lactulose/mannitol ratio)
Index test:Diagnostic model for intestinal barrier injury based on metabolomic profiling

Sponsors

General Hospital of the Eastern Theater Command of the People's Liberation Army of China (Jinling Hospital Affiliated to Nanjing University Medical School)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Critically Ill Patients: 1. Age 18 to 80 years; 2. APACHE II score = 12; 3. No history of gastrointestinal diseases or surgery; 4. Provision of informed consent for sample collection. Patients with Inflammatory Bowel Disease: 1. Age 18 to 80 years; 2. No infectious diseases within the past month; 3. Meeting the clinical diagnostic criteria for ulcerative colitis (UC) or Crohn's disease (CD) (confirmed by radiological, endoscopic, or pathological examination); 4. No history of other gastrointestinal diseases or surgery; 5. Provision of informed consent for sample collection. Healthy Controls: 1. Age 18 to 80 years, in good general health; 2. No infectious diseases within the past month; 3.No history of gastrointestinal diseases or surgery; 4. Provision of informed consent for sample collection. Inclusion criteria for abdominal surgery patients: 1. Age 18 to 80 years; 2. Patients undergoing elective abdominal surgery; 3. Agree to sample collection and have the corresponding informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with concomitant hepatic or renal dysfunction; 3. Patients with concomitant endocrine and metabolic diseases such as hypertension, diabetes, thyroid disorders, or other immune-related diseases; 4. Alcohol consumption or use of non-steroidal anti-inflammatory drugs, immunosuppressants, antimicrobial agents, probiotics, hormonal medications, gastric acid secretion inhibitors, or other drugs that may affect intestinal permeability within 2 weeks prior to enrollment; 5. Individuals with recent intestinal surgery or severe intestinal diseases: patients suffering from severe intestinal conditions, such as severe intestinal infections (e.g. cholera, severe bacillary dysentery) or intestinal ischemic diseases; 6. Known or suspected allergy to lactulose or mannitol.

Design outcomes

Primary

MeasureTime frame
Serum metabolites;Fecal metabolites;

Secondary

MeasureTime frame
Area Under the Receiver Operating Characteristic Curve;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactWang Xinying

General Hospital of the Eastern Theater Command of the People's Liberation Army of China (Jinling Hospital Affiliated to Nanjing University Medical School)

1104775184@qq.com+86 25 8086 0036

Outcome results

None listed

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