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NCT05406882
The Effects of Probiotics Combined With Glutamine in the Prevention and Treatment of Radiation Proctitis
Phase 2, PHASE3 trial testing Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules in Radiation Proctitis in 176 participants. Status unknown.
15 April 2024
Quick facts
| Lead sponsor | West China Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 176 |
| Start date | 15 April 2022 |
| Primary completion | 15 April 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules — full drug profile →
Conditions studied
- Radiation Proctitis — all drugs for Radiation Proctitis →
- Probiotics — all drugs for Probiotics →
- Glutamine — all drugs for Glutamine →
- Gut Microbiota — all drugs for Gut Microbiota →
Sponsor
West China Hospital
Who can join
Adults 18 to 75, any sex, with Radiation Proctitis or Probiotics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05406882
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Related trials
Other recruiting trials for Radiation Proctitis
Currently open trials in the same condition.
- NCT07378631 — Association Between Clinical Subtypes and Prognosis in Radiation Rectal Injury · recruiting
- NCT06776016 — Dietary Supplements to Treat Radiation-Induced Rectal Injury · Phase 2 · recruiting
Other West China Hospital trials
Trials by the same sponsor.
- NCT07583654 — Safety, Tolerability, and Preliminary Antitumor Activity of Cationic Peptide-IL22BP mRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07583914 — Safety, Tolerability, and Preliminary Antitumor Activity of Non-Cationic Peptide-CD47 siRNA in Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07492914 — Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT07507097 — Study on the Optimal Head Position for Patients With Severe Acute Ischemic Stroke · NA · not yet recruiting
- NCT07472933 — Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies · Phase 2 · not yet recruiting
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 NCT05406882 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by West China Hospital
- Last refreshed: 15 July 2022
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/NCT05406882.
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