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Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

This study has been completed.
Sponsor:
Collaborator:
DuPont Nutrition and Health
Information provided by (Responsible Party):
Yvonne Wettergren, Vastra Gotaland Region
ClinicalTrials.gov Identifier:
NCT03072641
First received: March 1, 2017
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
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 Intervention
Colon Cancer Dietary Supplement: ProBion Clinica

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

Resource links provided by NLM:


Further study details as provided by Yvonne Wettergren, Vastra Gotaland Region:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 20
Actual Study Start Date: June 3, 2010
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03072641

Sponsors and Collaborators
Vastra Gotaland Region
DuPont Nutrition and Health
Investigators
Principal Investigator: Yvonne A Wettergren, PhD Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden
  More Information

Responsible Party: Yvonne Wettergren, Associate professor, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03072641     History of Changes
Other Study ID Numbers: ALFGBG-542821
Study First Received: March 1, 2017
Last Updated: March 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 16, 2017