Clinical trial NCT05406882: The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis
Official title: The Effects of Bifidobacterium and Lactobacillus Tablets Combined With Compound Glutamine in the Prevention and Treatment of Radiation Proctitis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Radiation Proctitis
Probiotics
Glutamine
Gut Microbiota
Bifidobacterium
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of radiation proctitis
timeFrame: two months
Secondary outcomes:
measure: remission rate of radiation proctitis
timeFrame: two months
Other outcomes:
measure: Evaluation of radiation proctitis by LENT SOMA Score
timeFrame: two months
measure: Evaluation of radiation proctitis by rectal chemoradiotherapy toxicity scale
timeFrame: two months
measure: Evaluation of radiation proctitis by fiberoptic proctoscopy
timeFrame: two months
measure: changes in gut microbiota by 16S rRNA sequencing technology
timeFrame: two months
measure: Changes in serum inflammatory factors
timeFrame: two months
measure: QOL C29
timeFrame: two months
measure: QOL C30
timeFrame: two months
measure: tumor imaging assessment
timeFrame: two months
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Chengdu
country: China
facility: Xin Wang
state: Sichuan
Study officials:
affiliation: China, SiChuan West China Hospital
name: xin wang
role: PRINCIPAL_INVESTIGATOR
References: