Gut Microbiota Clinical Trial
Official title:
The Effects of Bifidobacterium and Lactobacillus Tablets Combined With Compound Glutamine in the Prevention and Treatment of Radiation Proctitis.
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.
Status | Recruiting |
Enrollment | 176 |
Est. completion date | September 30, 2024 |
Est. primary completion date | April 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital | Chengdu | Sichuan |
China | Xin Wang | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evaluation of radiation proctitis by LENT SOMA Score | Evaluation of radiation proctitis with clinical symptoms using LENT SOMA Score.The minimum value is 0, and maximum is 4. Higher scores mean a worse outcome. | two months | |
Other | Evaluation of radiation proctitis by rectal chemoradiotherapy toxicity scale | Evaluation of radiation proctitis with clinical symptoms using rectal chemoradiotherapy toxicity scale.The minimum value is 0, and maximum is 5. Higher scores mean a worse outcome. | two months | |
Other | Evaluation of radiation proctitis by fiberoptic proctoscopy | Evaluation of radiation proctitis with fiberoptic proctoscopy using Vienna Rectoscopy Score. The minimum value is 0, and maximum is 3/4. Higher scores mean a worse outcome. | two months | |
Other | changes in gut microbiota by 16S rRNA sequencing technology | To detect changes in gut microbiota with 16S rRNA sequencing,including changes in species diversity and abundance of gut microbiota. | two months | |
Other | Changes in serum inflammatory factors | Assess changes in serum inflammatory factors , including IL-2?IL-6,CRP?TNFa, etc. | two months | |
Other | QOL C29 | Assess patients' subjective feeling of life using EORTC QOL C29.The minimum value is 1, and maximum is 4. Higher scores mean a worse outcome. | two months | |
Other | QOL C30 | Assess patients' subjective feeling of life using EORTC QOL C30.The minimum value is 1, and maximum is 4. Higher scores mean a worse outcome. | two months | |
Other | tumor imaging assessment | Evaluation of tumor changes with imaging methods,including treatment response with complete response, partial response or stable disease according to RECIST 1.1 after 1 month after concurrent chemoradiotherapy. | two months | |
Primary | Incidence of radiation proctitis | Incidence of grade =2 radiation proctitis in combination therapy group | two months | |
Secondary | remission rate of radiation proctitis | remission rate of radiation proctitis after combined treatment in control group developed radiation proctitis of grade =2 | two months |
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