Clinical trial · Interventional
Prevention of Irinotecan Induced Diarrhea by Probiotics
Prevention of Irinotecan Induced Diarrhea by Probiotics: A Phase III Study
- 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)
Diarrhea is a relatively common complication in patients with cancer. At its inception, several mechanisms participated; malabsorption on the basis of mucositis induced by chemotherapy, dysbiosis induced by broad-spectrum antibiotics and predisposition to infectious diarrhea in immunocompromised patients. Some cytostatics and their metabolites can also induce diarrhea directly due to effect on the intestinal mucosa. Use of probiotics in prevention and treatment of diarrhea relies on both the theoretical assumptions and the results of several clinical trials. Lactic acid bacteria involved in the treatment of dysbiosis, compete for substrate with pathogenic bacteria, produce bacterio-cins, increase transepithelial resistance. Their enzymatic activity affects activation or deactivation of metabolites which cause diarrhea. Production of short chain fatty acids, which are important for the maintenance of intestinal mucosal cells also contributes to their antidiarrhoeal effect. This randomized, double-blind, placebo controlled, multicentre trial was designed to evaluate potential of probiotics to prevent grade 3-4 diarrhea in patients treated by irinotecan based chemotherapy during first 6 weeks of irinotecan based chemotherapy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diarrhea | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Probio-Tec® BG-VCap-6.5 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- active probiotic formula
- description
- Intervention: Probiotic formula Probio-Tec® BG-VCap-6.5 will be administered at a dose of 3x1 cps per day orally for 6 weeks. No premedication or patient monitoring after administration of probiotic formula is required. Probiotic formula may be taken after meals or snacks to reduce stomach upset. Swallow the capsule or in case of problems with swallowing, capsule can be opened, content mixed with small amount of food. Food must not be hot. Patients should receive full supportive care during the study, including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoetin, or bisphosphonates, when appropriate.
- interventionNames
- Drug: Probio-Tec® BG-VCap-6.5
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Intervention: Maltodextrin will be used for placebo group and will be administered at a the same dose as active formula (3x1 cps per day orally for 6 weeks). Patients should receive full supportive care during the study, including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrheal agents, analgesics, erythropoetin, or bisphosphonates, when appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * signed written informed consent * age \> 18 years * histologically proven colorectal cancer patients starting new line of chemotherapy based on irinotecan * ECOG PS 0 - 1 at study entry * life expectancy more than 3 months * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; Exclusion Criteria: * impossibility to take oral medication * active infection treated by antibiotic therapy * ileostoma * hypersensitivity to study drug * any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years. * serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator )
References
Publications (29)
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