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

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.

Study Overview

• Status: Recruiting
• Conditions: Probiotics; Gut Microbiota; Bifidobacterium; Radiation Proctitis; Glutamine
• Intervention / Treatment: Drug: Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: min ren, PhD/MD; Phone Number: +86 28 85423609; Email: renmin0502@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Xin Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combination therapy group; 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.	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; Other Names: Probiotics、Glutamine
No Intervention: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of radiation proctitis	Incidence of grade ≥2 radiation proctitis in combination therapy group	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
remission rate of radiation proctitis	remission rate of radiation proctitis after combined treatment in control group developed radiation proctitis of grade ≥2	two months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Changes in serum inflammatory factors	Assess changes in serum inflammatory factors , including IL-2、IL-6，CRP、TNFa, etc.	two months
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
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
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

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Anticipated): April 15, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Rectal Diseases; Proctitis
• Other Study ID Numbers: HX-H2112345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No