NCT04517045

The Study of Dachengqi Decoction Combined With Probiotic L92 to Improve the Prognosis of Patients With Severe Abdominal Hypertension

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 752 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Patients with severe infections, wounds (burns), and severe pancreatitis often have abdominal hypertension (IAH), which is an important objective manifestation of acute gastrointestinal failure in severe patients. Timely diagnosis and effective intervention can improve the treatment rate of patients. In the early stage, we conducted clinical exploration and observational research on the treatment of IAH with Dachengqi Decoction and Lactobacillus in the treatment of critically ill patients including the above diseases, and achieved significant clinical effects. On this basis, it is planned to verify the protective effect of Lactobacillus acidophilus L92, Dachengqi Decoction and the combination of the two on the gastrointestinal mucosal barrier function of patients with IAH and the regulation of the intestinal flora, and analyze the intestinal mucosal barrier The relationship between intestinal flora and the prognosis of IAH patients.

Conditions

• Dachengqi Decoction
• Probiotic L92

Interventions

Type	Name	Description
DRUG	Dachengqi decoction	Raw rhubarb 30g, Glauber's salt 30g, Citrus aurantium 20g, Magnolia officinalis 20g. The decoction was decocted uniformly in the decoction room of Xinhua Hospital, Shanghai Jiaotong University School of Medicine, and decocted 200 mL thickly, fed via nasogastric tube/nasal intestine tube and enema, 1 dose/d, and continued treatment until the end of the trial
DRUG	probiotic L9	L92 2 tablets/time, tid, oral or nasal feeding
OTHER	Conventional treatment	Conventional treatment

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-07-31
• Completion: 2022-09-30
• First posted: 2020-08-18
• Last updated: 2020-08-18