Bifidobacterium, Glutamine, Gut Microbiota, Probiotics, Radiation Proctitis
Conditions
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.
Interventions
DRUGLive Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules
Live Combined Bifidobacterium and Lactobacillus Tablets：probiotics. Compound Glutamine Entersoluble capsules：combined traditional Chinese medicine and glutamine
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of radiation proctitis | two months | Incidence of grade ≥2 radiation proctitis in combination therapy group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| remission rate of radiation proctitis | two months | remission rate of radiation proctitis after combined treatment in control group developed radiation proctitis of grade ≥2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of radiation proctitis by fiberoptic proctoscopy | two months | 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. |
| changes in gut microbiota by 16S rRNA sequencing technology | two months | To detect changes in gut microbiota with 16S rRNA sequencing，including changes in species diversity and abundance of gut microbiota. |
| Changes in serum inflammatory factors | two months | Assess changes in serum inflammatory factors , including IL-2、IL-6，CRP、TNFa, etc. |
| Evaluation of radiation proctitis by LENT SOMA Score | two months | 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. |
| QOL C30 | two months | 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. |
| tumor imaging assessment | two months | 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. |
| QOL C29 | two months | 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. |
| Evaluation of radiation proctitis by rectal chemoradiotherapy toxicity scale | two months | 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. |
Countries
China
Contacts
Primary Contactxin wang, PhD/MD
Backup Contactmin ren, PhD/MD
Outcome results
None listed