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| Name | Class |
|---|---|
| DuPont Nutrition and Health | INDUSTRY |
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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 Ë„ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 Ë„ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProBion Clinica | Experimental | Probiotic tablets yielding a daily dose of 1.4 x 10 Ë„ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 Ë„ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin. |
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| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProBion Clinica | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in microbiota composition after probiotics use | The microbiota composition is analysed at baseline and after probiotics use in tissue and faeces samples | 8-78 days depending on time elapsed from inclusion to surgical removal of tumor |
| Measure | Description | Time Frame |
|---|---|---|
| Epigenetic changes after probiotics use | DNA methylation levels are analysed at baseline and after probiotics use in tissue samples | 8-78 days depending on time elapsed from inclusion to surgical removal of tumor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne A Wettergren, PhD | Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40357388 | Derived | Wettergren Y, Rolny P, Lindegren H, Odin E, Rotter Sopasakis V, Keane S, Ejeskar K. Increased MLH1, MGMT, and p16INK4a methylation levels in colon mucosa potentially useful as early risk marker of colon cancer. Mol Cell Oncol. 2025 May 10;12(1):2503069. doi: 10.1080/23723556.2025.2503069. eCollection 2025. | |
| 35499706 | Derived |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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. |
| 28944067 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |