Gegen Qinlian Tang and Probiotics for Radiation Enteritis

NCT ID: NCT06836960

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Acute Radiation Enteritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Probiotic Therapy With Gegen Qinlian Tang

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiujiang No.1 People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lu Wang

Jiujiang NO.1 Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jiujiang NO.1 People's Hospital

Jiujiang, Jiangxi, China

Countries

China

Other Identifiers

S2021ZDYFN148

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

JJSDYRMYY-YXLL-2014-193

Identifier Type: -

Identifier Source: org_study_id