Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

NCT ID: NCT03072641

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-03

Study Completion Date

2016-03-31

Brief Summary

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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 ˄ 10 Bifidobacterium lactis Bl-04 (ATCC SD5219), 7x10 ˄ 9 Lactobacillus acidophilus NCFM (ATCC 700396), and 0.63 g inulin.

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ProBion Clinica

Intervention Type DIETARY_SUPPLEMENT

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ProBion Clinica

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DuPont Nutrition and Health

INDUSTRY

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yvonne Wettergren

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yvonne A Wettergren, PhD

Role: PRINCIPAL_INVESTIGATOR

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

References

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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.

Reference Type DERIVED
PMID: 40357388 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35499706 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28944067 (View on PubMed)

Other Identifiers

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ALFGBG-542821

Identifier Type: -

Identifier Source: org_study_id

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