Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

March 6, 2017 updated by: Yvonne Wettergren, Vastra Gotaland Region
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: 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.
Dietary supplement: ProBion Clinica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8-78 days depending on time elapsed from inclusion to surgical removal of tumor

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8-78 days depending on time elapsed from inclusion to surgical removal of tumor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Collaborators

DuPont Nutrition and Health

Investigators

  • Principal Investigator: Yvonne A Wettergren, PhD, Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 3, 2010

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (ACTUAL)

March 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALFGBG-542821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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