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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Radiation Proctitis Probiotics Glutamine Gut Microbiota Bifidobacterium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules

Intervention Type DRUG

Live Combined Bifidobacterium and Lactobacillus Tablets：probiotics. Compound Glutamine Entersoluble capsules：combined traditional Chinese medicine and glutamine

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Probiotics、Glutamine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No