NCT05406882

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

May 6, 2022

Last Update Submit

July 12, 2022

Conditions

Radiation ProctitisProbioticsGlutamineGut MicrobiotaBifidobacterium

Outcome Measures

Primary Outcomes (1)

  • Incidence of radiation proctitis

    Incidence of grade ≥2 radiation proctitis in combination therapy group

    two months

Secondary Outcomes (1)

  • remission rate of radiation proctitis

    two months

Other Outcomes (8)

  • Evaluation of radiation proctitis by LENT SOMA Score

    two months

  • Evaluation of radiation proctitis by rectal chemoradiotherapy toxicity scale

    two months

  • Evaluation of radiation proctitis by fiberoptic proctoscopy

    two months

  • +5 more other outcomes

Study Arms (2)

combination therapy group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsulesDRUG

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

Also known as: Probiotics、Glutamine
combination therapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Xin Wang

Chengdu, Sichuan, 610041, China

RECRUITING

Study Officials

  • xin wang

    China, SiChuan West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xin wang, PhD/MD

CONTACT

+86 28 85423609wangxin213@sina.com

min ren, PhD/MD

CONTACT

+86 28 85423609renmin0502@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2022

First Posted

June 7, 2022

Study Start

April 15, 2022

Primary Completion

April 15, 2024

Study Completion

September 30, 2024

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations

CN(2)