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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    176
  • sponsor
    West China Hospital
Updated on 27 July 2022

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.

Details
Condition Radiation Proctitis, Probiotics, Glutamine, Gut Microbiota, Bifidobacterium
Treatment Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules
Clinical Study IdentifierNCT05406882
SponsorWest China Hospital
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

locally advanced rectal adenocarcinoma diagnosed by histopathology; clinical stage T3/4 or N+(AJCC,8th), no metastasis; and planned to receive preoperative neoadjuvant concurrent chemoradiotherapy
without other malignant tumors
Those without serious heart, liver, kidney and other diseases
ECOG score: 0-1

Exclusion Criteria

Complicated with ulcerative colitis or Crohn's disease
Complicated with severe organ insufficiency, severe diabetes, and heart disease
Pregnant and lactating women
Abnormal bowel movements with systemic and metabolic diseases
The patient has a history of using systemic antibiotics and intestinal active bacteria in the past 1 month
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