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

Last updated: July 12, 2022
Sponsor: West China Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Hemorrhoids

Ulcerative Colitis (Pediatric)

Rectal Disorders

Treatment

N/A

Clinical Study ID

NCT05406882
HX-H2112345
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • locally advanced rectal adenocarcinoma diagnosed by histopathology; clinical stageT3/4 or N+(AJCC,8th), no metastasis; and planned to receive preoperative neoadjuvantconcurrent chemoradiotherapy.
  • without other malignant tumors;
  • Those without serious heart, liver, kidney and other diseases;
  • ECOG score: 0-1.

Exclusion

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 bacteriain the past 1 month.

Study Design

Total Participants: 176
Study Start date:
April 15, 2022
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • West China Hospital

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Xin Wang

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

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