Status:
UNKNOWN
The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis
Lead Sponsor:
West China Hospital
Conditions:
Radiation Proctitis
Probiotics
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 ent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT05406882
Start Date
April 15 2022
End Date
September 30 2024
Last Update
July 15 2022
Active Locations (2)
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1
West China Hospital
Chengdu, Sichuan, China, 610041
2
Xin Wang
Chengdu, Sichuan, China, 610041