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

Phase 2

Recruiting

• Conditions: Probiotics; Glutamine; Bifidobacterium; Radiation Proctitis; Gut Microbiota
• Interventions: Drug: Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules

• Registration Number: NCT05406882
• Lead Sponsor: West China Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-15
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-15
• Primary Completion: 2024-04-15
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
combination therapy group	Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules	From the first day of chemoradiotherapy, live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy.

Primary Outcome Measures

Name	Time	Method
Incidence of radiation proctitis	two months	Incidence of grade ≥2 radiation proctitis in combination therapy group

Secondary Outcome Measures

Name	Time	Method
remission rate of radiation proctitis	two months	remission rate of radiation proctitis after combined treatment in control group developed radiation proctitis of grade ≥2

Trial Locations

Locations (2)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China

Xin Wang; 🇨🇳 Chengdu, Sichuan, China