Using Probiotics to Reactivate Tumor Suppressor Genes in Colon Cancer

Vastra Gotaland Region

Status: Completed

Conditions: Colon Cancer

Treatments: Dietary Supplement: ProBion Clinica

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03072641

ALFGBG-542821

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

ProBion Clinica

Experimental group

Description:

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.

Treatment:

Dietary Supplement: ProBion Clinica

Control

No Intervention group