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NCT06836960: GQBT-RE
Gegen Qinlian Tang and Probiotics for Radiation Enteritis
Phase 1, PHASE2 trial testing Probiotic Therapy With Gegen Qinlian Tang in Acute Radiation Enteritis in 60 participants. Enrolling by invitation.
31 December 2026
Quick facts
| Lead sponsor | Jiujiang No.1 People's Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 June 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Probiotic Therapy With Gegen Qinlian Tang — full drug profile →
Conditions studied
- Acute Radiation Enteritis — all drugs for Acute Radiation Enteritis →
Sponsor
Jiujiang No.1 People's Hospital
Who can join
Adults 18 to 80, any sex, with Acute Radiation Enteritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Radiation-induced intestinal injury: from molecular mechanisms to clinical translation.
Wu W, Cai Y, Yang Z, Chen M, et al · · 2025 · cited 1× · PMID 40951837 · DOI 10.3389/or.2025.1613704
Verify or expand the search:
- PubMed search for NCT06836960
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06836960 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiujiang No.1 People's Hospital
- Last refreshed: 20 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06836960.
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