A randomized double-blind placebo-controlled trial of probiotics in post-surgical colorectal cancer

Liyana Zaharuddin, Norfilza Mohd Mokhtar, Khairul Najmi Muhammad Nawawi, Raja Affendi Raja Ali

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Our study aimed to determine the effect of probiotic consumption containing six viable microorganisms of 30 × 1010 cfu Lactobacillus and Bifidobacteria strains for six months on clinical outcomes and inflammatory cytokines (TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22) in patients with colorectal cancer. METHODS: Fifty-two patients with colorectal cancer were randomized at four weeks after surgery to receive either a placebo (n = 25) or 30 billion colony-forming unit (CFU) of a mixture of six viable strains including 107 mg of Lactobacillus acidophilus BCMC® 12,130, Lactobacillus lactis BCMC® 12,451, Lactobacillus casei subsp BCMC® 12,313, Bifidobacterium longum BCMC® 02120, Bifidobacterium bifidum BCMC® 02290 and Bifidobacterium infantis BCMC® 02129 (n = 27). Patients were instructed to take the product orally twice daily for six months. Infection status, diarrhea or hospital admission were recorded throughout the study. Blood was taken pre- and post-intervention to measure TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22 using ELISA multiplex kit. RESULTS: The majority of cases (~ 70%) were in Duke's C colorectal cancer for both groups. No surgical infection occurred and no antibiotics were required. Chemotherapy induced diarrhea was observed in both groups. Significant reduction in the level of pro-inflammatory cytokine, TNF-α, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22 were observed in CRC patients who received probiotics as compared to pre-treatment level (P < 0.05). However, there was no significant difference in the IFN-γ in both groups. CONCLUSIONS: We have shown that probiotics containing six viable microorganisms of Lactobacillus and Bifidobacteria strains are safe to be consumed at four weeks after surgery in colorectal cancer patients and have reduced pro-inflammatory cytokines (except for IFN-gamma). Probiotic may modify intestinal microenvironment resulting in a decline in pro-inflammatory cytokines. TRIAL REGISTRATION: NCT03782428; retrospectively registered on 20th December 2018.

Original languageEnglish
Number of pages1
JournalBMC gastroenterology
Volume19
Issue number1
DOIs
Publication statusPublished - 24 Jul 2019

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Interleukin-17
Probiotics
Colorectal Neoplasms
Placebos
Lactobacillus
Interleukin-12
Interleukin-10
Cytokines
Interleukin-6
Bifidobacterium
Diarrhea
Lactobacillus acidophilus
Lactobacillus casei
Infection
Stem Cells
Enzyme-Linked Immunosorbent Assay
Anti-Bacterial Agents
Drug Therapy
interleukin-22

Keywords

  • Bifidobacterium spp.
  • Colorectal cancer
  • Cytokines
  • Lactobacillus spp.
  • Probiotic

ASJC Scopus subject areas

  • Gastroenterology

Cite this

A randomized double-blind placebo-controlled trial of probiotics in post-surgical colorectal cancer. / Zaharuddin, Liyana; Mohd Mokhtar, Norfilza; Muhammad Nawawi, Khairul Najmi; Raja Ali, Raja Affendi.

In: BMC gastroenterology, Vol. 19, No. 1, 24.07.2019.

Research output: Contribution to journalArticle

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AU - Zaharuddin, Liyana

AU - Mohd Mokhtar, Norfilza

AU - Muhammad Nawawi, Khairul Najmi

AU - Raja Ali, Raja Affendi

PY - 2019/7/24

Y1 - 2019/7/24

N2 - BACKGROUND: Our study aimed to determine the effect of probiotic consumption containing six viable microorganisms of 30 × 1010 cfu Lactobacillus and Bifidobacteria strains for six months on clinical outcomes and inflammatory cytokines (TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22) in patients with colorectal cancer. METHODS: Fifty-two patients with colorectal cancer were randomized at four weeks after surgery to receive either a placebo (n = 25) or 30 billion colony-forming unit (CFU) of a mixture of six viable strains including 107 mg of Lactobacillus acidophilus BCMC® 12,130, Lactobacillus lactis BCMC® 12,451, Lactobacillus casei subsp BCMC® 12,313, Bifidobacterium longum BCMC® 02120, Bifidobacterium bifidum BCMC® 02290 and Bifidobacterium infantis BCMC® 02129 (n = 27). Patients were instructed to take the product orally twice daily for six months. Infection status, diarrhea or hospital admission were recorded throughout the study. Blood was taken pre- and post-intervention to measure TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22 using ELISA multiplex kit. RESULTS: The majority of cases (~ 70%) were in Duke's C colorectal cancer for both groups. No surgical infection occurred and no antibiotics were required. Chemotherapy induced diarrhea was observed in both groups. Significant reduction in the level of pro-inflammatory cytokine, TNF-α, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22 were observed in CRC patients who received probiotics as compared to pre-treatment level (P < 0.05). However, there was no significant difference in the IFN-γ in both groups. CONCLUSIONS: We have shown that probiotics containing six viable microorganisms of Lactobacillus and Bifidobacteria strains are safe to be consumed at four weeks after surgery in colorectal cancer patients and have reduced pro-inflammatory cytokines (except for IFN-gamma). Probiotic may modify intestinal microenvironment resulting in a decline in pro-inflammatory cytokines. TRIAL REGISTRATION: NCT03782428; retrospectively registered on 20th December 2018.

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KW - Bifidobacterium spp.

KW - Colorectal cancer

KW - Cytokines

KW - Lactobacillus spp.

KW - Probiotic

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