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NCT03072641 Clinical Trial

Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

Colon Cancer Clinical Trial

Official title:
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03072641
Other study ID # ALFGBG-542821
Secondary ID
Status Completed
Phase N/A
First received March 1, 2017
Last updated March 6, 2017
Start date June 3, 2010
Est. completion date March 2016

Study information
Verified date March 2017
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• ProBion Clinica

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Vastra Gotaland Region DuPont Nutrition and Health

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in microbiota composition after probiotics use The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples 8-78 days depending on time elapsed from inclusion to surgical removal of tumor
Secondary Epigenetic changes after probiotics use DNA methylation levels are analysed at baseline and after probiotics use in tissue samples 8-78 days depending on time elapsed from inclusion to surgical removal of tumor
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