Gegen Qinlian Tang and Probiotics for Radiation Enteritis (GQBT-RE)

February 15, 2025 updated by: Lu Wang, Jiujiang No.1 People's Hospital

The Clinical Efficacy of Gegen Qinlian Tang Combined with Bifidobacterium Triple Viable Capsules in the Prevention and Treatment of Radiation Enteritis

The purpose of this clinical study is to evaluate whether Bifidobacterium Triple Viable Capsules, alone or in combination with Gegen Qinlian Decoction, can effectively prevent and treat acute radiation enteritis in patients undergoing abdominal or pelvic radiotherapy.

The study aims to answer the following question: Can probiotics, with or without the addition of herbal medicine, reduce the incidence and severity of radiation-induced intestinal injury and improve the quality of life for patients during and after radiotherapy?

A total of 60 patients with malignant tumors receiving abdominal or pelvic radiotherapy will be recruited and randomly assigned to one of three groups: a control group (no intervention), a probiotics-only group (Bifidobacterium Triple Viable Capsules, three capsules twice daily), and a combination therapy group (probiotics with modified Gegen Qinlian Decoction tailored to individual symptoms).

The primary outcome will be the incidence and severity of acute radiation enteritis, assessed using the RTOG/EORTC grading criteria (0-IV levels). Daily observations will be recorded during radiotherapy, with follow-up lasting three months after the completion of treatment.

This study seeks to provide evidence for the use of probiotics and herbal medicine as effective strategies to mitigate the side effects of radiotherapy and improve patient outcomes.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Jiujiang, Jiangxi, China, 3320000
        • Jiujiang No.1 People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:1.Age:Participants aged 18 to 80 years.2.Diagnosis:

Patients diagnosed with malignant tumors confirmed by cytological or pathological examination.Patients scheduled for abdominal or pelvic radiotherapy based on treatment guidelines.3Cognitive and Communication Ability:Participants must have clear consciousness and normal cognitive abilities to communicate effectively.4.Consent:Participants must provide written informed consent and agree to participate in the study.

Family members must also provide consent if applicable.5.Willingness to Cooperate:Participants must be willing to comply with the study procedures and requirements.

Exclusion Criteria:1.History of Severe Intestinal Diseases:Patients with a history of severe intestinal diseases, including ischemic bowel disease, ulcerative colitis, Crohn's disease, or other chronic inflammatory bowel conditions.2.Recent Antibiotic Use:Patients who have received antibiotic treatment within the past 2 years.3.Severe Organ Dysfunction:Patients with severe liver or kidney dysfunction, as determined by clinical assessment or laboratory tests.4.Comorbidities and Other Major Diseases:

Patients with other serious illnesses that may interfere with the study protocol or compliance, including but not limited to cardiovascular, respiratory, or neurological diseases.5.Inability to Participate:Patients unable to cooperate with the study procedures due to physical or psychological reasons.Patients who are likely to withdraw midway through the study.6.Incomplete Medical Records or Refusal to Share Data:Patients who refuse to share their medical records or have incomplete medical documentation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics With Gegen Qinlian Tang Group
Participants in this group will receive an oral placebo matched in appearance to the Bifidobacterium Triple Viable Capsules, taken three times daily for 8 weeks. No active interventions will be administered in this group, serving as the placebo control.
Drug: Probiotic Therapy With Gegen Qinlian Tang
This intervention includes the oral administration of Bifidobacterium Triple Viable Capsules (0.5 g, three times daily) combined with Gegen Qinlian Tang (200 mL, twice daily) for 8 weeks. The combination therapy is designed specifically for the prevention and treatment of radiation enteritis, differentiating it from probiotics or herbal therapies used alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Acute Radiation Enteritis
Time Frame: From the start of radiotherapy to 3 months post-treatment
The incidence of acute radiation enteritis will be assessed using the RTOG/EORTC grading criteria (Grade 0-IV). Symptoms such as diarrhea, abdominal pain, and mucus secretion will be monitored daily during radiotherapy and up to three months post-treatment. The outcome will measure the proportion of patients experiencing Grade II or higher symptoms in each study arm. This assessment aims to evaluate the effectiveness of Bifidobacterium Triple Viable Capsules, alone or in combination with Gegen Qinlian Decoction, in reducing the incidence of radiation enteritis.
From the start of radiotherapy to 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiujiang No.1 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJSDYRMYY-YXLL-2014-193
  • S2021ZDYFN148 (Other Grant/Funding Number: Jiujiang City Key Research and Development Plan)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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