Clinical trial · Interventional
Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer
Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer: Randomized Double-blind Placebo-controlled Trial
NCT03705442CI-TRIAL-00035282Probat-tmcc-17unknownPhase 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)
The research will be prospective, randomised, placebo controlled and double-blinded.The research will be carried on with regards to Helsinki Declaration and following the guidelines of Good Clinical Practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| loperamide ("Seldiar") | Drug | — | UNRESOLVED |
| Omni-Biotic 10 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: loperamide ("Seldiar")
- type
- EXPERIMENTAL
- label
- Probiotics
- description
- Omni-Biotic 10
- interventionNames
- Dietary Supplement: Omni-Biotic 10
- Drug: loperamide ("Seldiar")
Primary outcomes (1)
- measure
- Incidence of grade III/IV diarrhoea between the two groups of patients
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A histologically confirmed diagnosis of colorectal cancer with metastasis; * Patients older than 18 years of age; * Patients starting first line of chemotherapy (FOLFIRI protocol); * Signed patient consent form. Exclusion Criteria: * Present ileostomy; * Decompensated patients; * Terminal stage patients (\<6 months life expectancy); * Patients not mentally able to adhere to the protocol; * Patients using \>3 yoghurts per week or any other probiotics; * Or any other condition which would not allow safe administration of the drugs.
References
Publications (0)
Data not yet available
No reference posted for this study.