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Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072641
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
DuPont Nutrition and Health
Information provided by (Responsible Party):
Yvonne Wettergren, Vastra Gotaland Region

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colon Cancer Dietary Supplement: ProBion Clinica Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Actual Study Start Date : June 3, 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072641


Sponsors and Collaborators
Vastra Gotaland Region
DuPont Nutrition and Health
Investigators
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Principal Investigator: Yvonne A Wettergren, PhD Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yvonne Wettergren, Associate professor, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03072641    
Other Study ID Numbers: ALFGBG-542821
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yvonne Wettergren, Vastra Gotaland Region:
Probiotics
Epigenetics
Microbiota
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases