Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Not Applicable
Completed
- Conditions
- Colon Cancer
- Interventions
- Dietary Supplement: ProBion Clinica
- Registration Number
- NCT03072641
- Lead Sponsor
- Vastra Gotaland Region
- Brief Summary
The purpose of the study is to determine if probiotic bacteria have a beneficial effect on the colon cancer-associated microbiota and epigenetic alterations in colon cancer. Dietary supplementation consists of two ProBion Clinica tablets, yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- At least one malignant tumor in the colon
Exclusion Criteria
- Study subjects with adenomas, or
- who received recent antibiotic therapy or
- consumed probiotics regularly were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ProBion Clinica ProBion Clinica Probiotic tablets yielding a daily dose of 1.4 x 10 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.
- Primary Outcome Measures
Name Time Method Changes in microbiota composition after probiotics use 8-78 days depending on time elapsed from inclusion to surgical removal of tumor The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples
- Secondary Outcome Measures
Name Time Method Epigenetic changes after probiotics use 8-78 days depending on time elapsed from inclusion to surgical removal of tumor DNA methylation levels are analysed at baseline and after probiotics use in tissue samples