Diarrhea
Conditions
Interventions
G07.203.300.456.500
It is a randomized controlled clinical study with two arms, double-blind. A total of 30 eligible individuals will be probabilistically allocated to one of the two groups. Using R Software, a random se
Sponsors
Universidade Federal de São Paulo
Irmandade da Santa Casa de Misericórdia de São Paulo
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 85 years old; Diagnosis of primary gastrointestinal tract tumor (esophagus, stomach, pancreas, colon and rectum); Planning to start chemotherapy treatment with chemotherapy protocols containning irinotecan and/or fluoropyrimidines; Performance scale according to the Eastern Cooperative Oncology Group (ECOG) between 0-2
Exclusion criteria
Exclusion criteria: Severe systemic diseases including heart disease, coagulopathies, renal and hepatic dysfunction; History of severe diarrhea during previous treatment; Use of probiotics, prebiotics up to 2 months before recruitment; Pregnant and lactating women; Incapable patient; Not signed the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effectiveness of using probiotics in preventing diarrhea induced by irinotecan and/or fluoropyrimidines in patients diagnosed with gastrointestinal tract cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterize microbial population in the gut microbiota in the pre and post chemotherapy stages through the amplification and sequencing of the 16S ribosomal RNA gene.;Evaluate the impact of use of probiotics on the gut microbiota in patients undergoing chemotherapy regimens that include irinotecan and/or fluoropyrimidines and their role in preventing chemotherapy-induced diarrhea. | — |
Countries
Brazil
Contacts
Public ContactGabriel de Souza
Universidade Federal de São Paulo
Outcome results
None listed