Colon Cancer
Conditions
Keywords
Probiotics, Epigenetics, Microbiota
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.
Interventions
DIETARY_SUPPLEMENTProBion Clinica
Sponsors
DuPont Nutrition and Health
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed