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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

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date March 7, 2017
Actual Study Start Date  ICMJE June 3, 2010
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)		 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Official Title  ICMJE Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Colon Cancer
Intervention  ICMJE Dietary Supplement: ProBion Clinica
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: ProBion Clinica
  • No Intervention: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2017)		 20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03072641
Other Study ID Numbers  ICMJE ALFGBG-542821
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Yvonne Wettergren, Vastra Gotaland Region
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vastra Gotaland Region
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE DuPont Nutrition and Health
Investigators  ICMJE
Principal Investigator: Yvonne A Wettergren, PhD Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden
PRS Account Vastra Gotaland Region
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP