Back to resultsUsing Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Primary Purpose
Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ProBion Clinica
Sponsored by
About this trial
This is an interventional basic science trial for Colon Cancer focused on measuring Probiotics, Epigenetics, Microbiota
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ProBion Clinica
Control
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes in microbiota composition after probiotics use
The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples
Secondary Outcome Measures
Epigenetic changes after probiotics use
DNA methylation levels are analysed at baseline and after probiotics use in tissue samples
Full Information
NCT ID
NCT03072641
First Posted
March 1, 2017
Last Updated
March 6, 2017
Sponsor
Vastra Gotaland Region
Collaborators
DuPont Nutrition and Health
1. Study Identification
Unique Protocol Identification Number
NCT03072641
Brief Title
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Official Title
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 3, 2010 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vastra Gotaland Region
Collaborators
DuPont Nutrition and Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Probiotics, Epigenetics, Microbiota
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProBion Clinica
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
ProBion Clinica
Primary Outcome Measure Information:
Title
Changes in microbiota composition after probiotics use
Description
The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples
Time Frame
8-78 days depending on time elapsed from inclusion to surgical removal of tumor
Secondary Outcome Measure Information:
Title
Epigenetic changes after probiotics use
Description
DNA methylation levels are analysed at baseline and after probiotics use in tissue samples
Time Frame
8-78 days depending on time elapsed from inclusion to surgical removal of tumor
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne A Wettergren, PhD
Organizational Affiliation
Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35499706
Citation
Keane S, Herring M, Rolny P, Wettergren Y, Ejeskar K. Inflammation suppresses DLG2 expression decreasing inflammasome formation. J Cancer Res Clin Oncol. 2022 Sep;148(9):2295-2311. doi: 10.1007/s00432-022-04029-7. Epub 2022 May 2.
Results Reference
derived
PubMed Identifier
28944067
Citation
Hibberd AA, Lyra A, Ouwehand AC, Rolny P, Lindegren H, Cedgard L, Wettergren Y. Intestinal microbiota is altered in patients with colon cancer and modified by probiotic intervention. BMJ Open Gastroenterol. 2017 Jul 3;4(1):e000145. doi: 10.1136/bmjgast-2017-000145. eCollection 2017.
Results Reference
derived
Learn more about this trial
Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
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