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An Evaluation of Probiotic in the Clinical Course of Patients With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03782428
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Liyana Zaharuddin, National University of Malaysia

Brief Summary:
Colorectal cancer (CRC) is the most common cancer for men and the second most common for women. Several studies have shown that gut microbiome may play a role in triggering intestinal inflammation that leads to the development of CRC. Gut microbiome is the collection of microorganisms that inhabit the gut. Therefore, manipulation of the gut microbiome via administration of probiotics may potentially improve the health and nutritional status in patients with CRC. The aims of this study are to investigate the role of probiotic functional foods in reducing CRC-related inflammatory markers and symptom alleviation.Participants will be needed to complete an information details form which includes information on age, medical history, background details and diet. Participants are required to consume the investigational product twice daily for six months. Blood samples will be collected prior to surgery and at 6th months post product consumption. These blood samples will be processed and analysed.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: Probiotic Other: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized double-blind placebo controlled trial was performed in patients who were diagnosed with colorectal cancer and planned for colorectal resection. Four weeks postoperative, patients were randomized to receive either placebo or 3g X 1010 probiotic containing six viable microorganism of Lactobacillus and Bifidobacterium strains for six months.
Masking: Double (Participant, Investigator)
Masking Description: both probiotic and placebo product were labelled as either A or B and was given to the patients through simple randomization.
Primary Purpose: Supportive Care
Official Title: Probiotic Effects On Clinical and Circulating Inflammatory Cytokines Status In Patients With Colorectal Cancer: A Randomised Double Blind Clinical Trial
Actual Study Start Date : August 26, 2016
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Probiotic group
27 participants received probiotics twice daily for six months
Dietary Supplement: Probiotic
30 billions colony-forming unit (CFU) of a mixture of six viable strains including 107 mg of Lactobacillus acidophilus BCMC® 12130, Lactobacillus lactis BCMC® 12451, Lactobacillus casei subsp BCMC® 12313, Bifidobacterium longum BCMC® 02120, Bifidobacterium bifidum BCMC® 02290 and Bifidobacterium infantis BCMC® 02129
Other Name: HEXBIO

Placebo Comparator: Placebo group
25 participants received placebo twice daily for six months
Other: Placebo
Placebo samples produced were identical to the probiotics in term of taste and texture without live microorganisms.




Primary Outcome Measures :
  1. Level of circulating inflammatory cytokines (TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL17C &IL-22) pre and post intervention. [ Time Frame: Change from pre intervention baseline level at post six months intervention. ]
    the level of eight colorectal cancer related inflammatory cytokines (in pg/mL) were measured and compared between pre and post intervention in both probiotic and placebo group.


Secondary Outcome Measures :
  1. Number of patients with chemotherapy induced diarrhoea assessed by CTCAE v3.0 [ Time Frame: During the six month intervention period. ]
    Patients who underwent chemotherapy during the six months intervention period were reviewed and evaluated based on Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and above.
  • Diagnosed with colorectal cancer
  • Planned for colorectal resection

Exclusion Criteria:

  • Received antibiotics 2 weeks prior to recruitment
  • Consumed pro/pre/symbiotic product 2 weeks prior to recruitment,
  • Patients with recurrent colorectal cancer
  • Advanced metastasis
  • Nursing or pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782428


Sponsors and Collaborators
Dr. Liyana Zaharuddin
Investigators
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Principal Investigator: Associate Professor Dr. Raja Affendi Raja Ali Faculty Of Medicine, Universiti Kebangsaan Malaysia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Liyana Zaharuddin, Research Assistant Physiology Department, Faculty of Medicine, National University of Malaysia
ClinicalTrials.gov Identifier: NCT03782428     History of Changes
Other Study ID Numbers: FPR.4/244/TRGS/2/2014/UKM/02/3
TRGS/2/2014/UKM/02/3 ( Other Grant/Funding Number: Ministry of Education, Malaysia )
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are bind to the Institutional Review Board Universiti Kebangsaan Malaysia Medical Research Ethics Committee rules and regulations where recruited patients identity and data are kept confidential and will only be allowed to access by the institution.

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases