Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

NCT03072641 | Completed

• 1 other identifier: ALFGBG-542821
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colon Cancer

Keywords

Probiotics; Epigenetics; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Epigenetic changes after probiotics use

  8-78 days depending on time elapsed from inclusion to surgical removal of tumor

Study Arms (2)

ProBion Clinica

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

ProBion Clinica DIETARY_SUPPLEMENT

ProBion Clinica

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least one malignant tumor in the colon

You may not qualify if:

• Study subjects with adenomas, or
• who received recent antibiotic therapy or
• consumed probiotics regularly were excluded.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• DuPont Nutrition and Health: collaborator

Related Publications (3)

• 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.

  PMID: 40357388 DERIVED

• 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.

  PMID: 35499706 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.

  PMID: 28944067 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Yvonne A Wettergren, PhD

  Dept. of surgery, Sahlgrenska Univ. Hospital, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 7, 2017
• Study Start: June 3, 2010
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share