Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ProBion Clinica

Dietary Supplement

Primary outcomes

Changes in microbiota composition after probiotics use

Time frame: 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 outcomes

Epigenetic changes after probiotics use

Time frame: 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

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

DuPont Nutrition and Health

Registry information

Important dates

Study start: 2010
Primary completion: 2016
Study completion: 2016
First posted: Mar 7, 2017
Registry last updated: Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed