Modulation of the Gut Microbiome for Cancer Therapy

Interventions: Group 1: A probiotic product OMNi-BiOTiC from the company Allergosan containing a mix of 10 probiotic bacterial strains will be administered orally in lyophilized form. Administration will be applied once daily with one dose equivalent to 5 * 109 colony forming units (cfu), in the morning over a period of 6 months.
Screening-phase will take up to two weeks and will be followed by a treatment period of 24 weeks. In Total 4 visits will be performed: Screening visit between -14 to -1 days before baseline. Treatment duration with probiotic product will be 24 weeks starting at the baseline visit. A study visit will be performed at week 8. End of treatment visit (EOT) takes place at week 24.
At each visit, physical examination takes place and vital signs, questionnaires (quality of life and dietary) as well as adverse events will be documented. At screening visit, study visit and EOT visit serum and whole blood as well as stool samples are collected for further analyses.
Primary outcome(s): Demonstrate a persistent modification of the intestinal microbiome in the feces (stool) of the participants following Bacteria administration as measured by metagenomics analysis by Shotgun Sequencing. Analyses are performed at the beginning of the study, after 8 weeks and at the end of the study after 24 weeks.
Study Design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: other