Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer
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ClinicalTrials.gov Identifier: NCT03072641 |
Recruitment Status :
Completed
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
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Condition or disease | Intervention/treatment | Phase |
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Colon Cancer | Dietary Supplement: ProBion Clinica | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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Dietary Supplement: ProBion Clinica |
No Intervention: Control |
- 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
- 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

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

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
Principal Investigator: | Yvonne A Wettergren, PhD | Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Probiotics Epigenetics Microbiota |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |