Clinical trial · Interventional
Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients
NCT06783153CI-TRIAL-00084873not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Radiation Enteritis | — | UNRESOLVED | — |
| Bladder (Urothelial, Transitional Cell) Cancer | — | UNRESOLVED | — |
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Pelvic Radiotherapy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy Induced Diarrhea | — | UNRESOLVED | — |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rifaximin | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rifaximin 550 MG | Drug | — | UNRESOLVED |
| Standard Care Chemoradiation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- interventionNames
- Drug: Standard Care Chemoradiation
- type
- EXPERIMENTAL
- label
- Patients will receive Rifaximin 550 MG in addition to Pelvic Radiotherapy with/not chemotherapy
- interventionNames
- Drug: Rifaximin 550 MG
Primary outcomes (1)
- measure
- The difference in the incidence and severity of radiotherapy induced diarrhea grade 2 or more according to Common Terminology Criteria for Adverse Events (CTCAE)in cancer patients undergo pelvic irradiation.
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers. * Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment. Exclusion Criteria: * Patients who have a record of intestinal resection in their medical history. * Patients with a medical background of irritable bowel syndrome. * Patients with a history of inflammatory bowel disease. * Patients who regularly take anti-diarrheal medications before commencing radiotherapy. * Patients experiencing diarrhea at the outset of the study. * Patients with compromised immune systems, such as those who are HIV positive or using immunosuppressive medications. * Pregnant or lactating woman. * Patients allergic to rifamycin.
References
Publications (0)
Data not yet available
No reference posted for this study.