drugset / Trial / NCT05406882

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

NCT05406882 ↗

Phase 2/3 Unknown 176 enrolled West China Hospital
RandomizedCrossoverOpen-labelPrevention

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.

Timeline

Start
2022-04-15
Primary completion
2024-04-15
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Compound Glutamine Entersoluble capsules Traditional medicine (herbal / TCM) — Oral
Subject Live Combined Bifidobacterium and Lactobacillus Tablets Other / unclassified 2000 mg Oral

Indications