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Study on the Mechanism of Auricular Acupoints in Sepsis Patients with Acute Gastrointestinal Dysfunction Differentiated as Qi Stagnation and Blood Stasis Syndrome through Combined Gut Microbiota Gene Sequencing and Metabolomic Analysis

Study on the Mechanism of Auricular Acupoints in Sepsis Patients with Acute Gastrointestinal Dysfunction Differentiated as Qi Stagnation and Blood Stasis Syndrome through Combined Gut Microbiota Gene Sequencing and Metabolomic Analysis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121486
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Acute gastrointestinal dysfunction in sepsis

Interventions

Non-Gastrointestinal Dysfunction Group:None
Gastrointestinal Dysfunction Group:None

Sponsors

Zhejiang Provincial Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age > 65 years and meeting the diagnostic criteria for sepsis. 2.Meeting or not meeting the diagnostic criteria for Acute Gastrointestinal Injury (AGI), diagnosed according to the AGI guidelines proposed by the European Society of Intensive Care Medicine (ESICM) in 2012. Briefly described as follows: AGI Grade I: temporary impairment of gastrointestinal function with spontaneous recovery; AGI Grade II: gastrointestinal dysfunction that does not recover spontaneously but improves with medication or other interventions; AGI Grade III: gastrointestinal dysfunction that cannot be restored by conventional treatment; AGI Grade IV: life-threatening gastrointestinal failure affecting multiple organs. 3.If meeting the diagnostic criteria for AGI, the patient must also meet the criteria for sepsis-associated gastrointestinal dysfunction of the Qi stagnation and blood stasis type, as assessed based on the "Expert Consensus on Integrated Traditional Chinese and Western Medicine for Secondary Sepsis-Related Gastrointestinal Dysfunction" and evaluation by a professional TCM practitioner.

Exclusion criteria

Exclusion criteria: 1. Patients under 65 years of age; 2. Pregnant women; 3. Patients who refuse to sign the informed consent form; 4. Patients unable to provide stool specimens; 5. Patients with primary gastrointestinal lesions upon ICU admission, such as intestinal malignant tumors, inflammatory bowel disease, or other intestinal disorders; 6. Individuals who have participated in other trials and have withdrawn from the study; 7. Patients with a life expectancy of less than 72 hours.

Design outcomes

Primary

MeasureTime frame
Gut Microbiota Composition;

Secondary

MeasureTime frame
Liver and kidney function and cardiac enzyme profile;Gastrointestinal symptoms (e.g., abdominal pain, diarrhea);Metabolomics;Mortality;Disease Severity;Inflammatory markers;

Countries

China

Contacts

Public ContactShu Lei

Zhejiang Provincial Hospital of TCM

13588132236@163.com+86 571 8662 0356

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026