NCT05406882

The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis

The Effects of Bifidobacterium and Lactobacillus Tablets Combined With Compound Glutamine in the Prevention and Treatment of Radiation Proctitis.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Radiation proctitis is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. Through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. And through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. To further explore the related pathways and mechanisms affecting radiation proctitis.

Conditions

• Radiation Proctitis
• Probiotics
• Glutamine
• Gut Microbiota
• Bifidobacterium

Interventions

Type	Name	Description
DRUG	Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules	Live Combined Bifidobacterium and Lactobacillus Tablets：probiotics. Compound Glutamine Entersoluble capsules：combined traditional Chinese medicine and glutamine

Timeline

• Start date: 2022-04-15
• Primary completion: 2024-04-15
• Completion: 2024-09-30
• First posted: 2022-06-07
• Last updated: 2022-07-15

Locations

2 sites across 1 country: China