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

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406882
• Other study ID #: HX-H2112345
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 15, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2022
• Source: West China Hospital
• Contact: xin wang, PhD/MD
• Phone: +86 28 85423609
• Email: wangxin213[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bifidobacterium
• Glutamine
• Gut Microbiota
• Probiotics
• Proctitis
• Radiation Proctitis

Intervention

Drug:
• Live 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

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan
China	Xin Wang	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

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