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

Sichuan University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Glutamine; Gut Microbiota; Radiation Proctitis; Bifidobacterium; Probiotics

Treatments: Drug: Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05406882

HX-H2112345

Details and patient eligibility

About

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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

combination therapy group

Experimental group

Description:

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.

Treatment:

Drug: Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules

control group

No Intervention group

Description:

After the start of chemoradiotherapy, the control group don't take the experimental drug orally . When patients have radiation proctitis of grade ≥2, they would be crossed over to the combined treatment group：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.