Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer

• Status: Unknown status
• Trial end date: 2020-02-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marin Golčić
• Treatments: Antidiarrheals; Loperamide

Criteria

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.