An Evaluation of Probiotic in the Clinical Course of Patients With Colorectal Cancer
NCT ID: NCT03782428
Last Updated: 2018-12-20
Study Results
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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COMPLETED
NA
52 participants
INTERVENTIONAL
2016-08-26
2018-11-26
Brief Summary
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Detailed Description
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METHODS:
A randomized, double-blind, placebo controlled trial were performed involving patients who were diagnosed with colorectal cancer and planned for colorectal resection in Universiti Kebangsaan Malaysia Medical Centre (UKMMC)
SAMPLE CALCULATION:
The effect of the intervention was described using relative risks and 95% confidence intervals and per-protocol analyses will be performed. Prior data indicate that the failure rate among controls is 0.8. If the true failure rate for experimental subjects is 0.4, the study required 22 experimental subjects and 22 control subjects to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.An uncorrected chi-squared statistic will be applied to evaluate this null hypothesis. Assuming the dropout rate of 30%, the total patients required for this interventional study for the CRC patients is 60 (30 patients for each arm).
PATIENTS CLINICAL ASSESSMENT:
Patient clinical characteristics including age, gender, smoking habits, comorbidities, cancer stage, tumour pathological subtype and site were identified. Recruited patients were randomized through simple randomization into either treated with probiotic or placebo. Trial unblinding was done upon completion of data analysis. Patients who underwent chemotherapy during the six months intervention period were reviewed and chemotherapy induced diarrhoea were evaluated based on Common Terminology Criteria for Adverse Events version 3.0 (CTCAEv3.0).
TREATMENT PRODUCT AND PROCEDURE:
Probiotics product involved in the study was HEXBIO® manufactured by B-Crobes Laboratories Sdn. Bhd., Malaysia. HEXBIO® contains 30 billions colony-forming unit (CFU) of six viable Lactobacillus and Bifidobacteria 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. Placebo samples produced were identical to the probiotics in term of taste and texture without live microorganisms. Both samples were prepared in a form of granules placed in aluminium foil sachets and kept in room temperature. HEXBIO® was labelled as AGE 1 while placebo as AGE 2.
In order to ensure post-surgery antibiotics given will not interfere with the study results, patients were instructed to consume the product four weeks after their surgeries. Patients were required to take the products orally twice daily for six months. Good compliance were considered when patients consumed more than 70% of total products given. Anything less than this was regarded as non-compliance.
BLOOD SAMPLE COLLECTION:
Prior to surgery, five mL of blood was taken from all the recruited patients. Blood was taken into BD vacutainer and allowed to clot for 30 minutes. It was then centrifuged for 15 minutes at 1000Xg where the separated serum was stored in -80°C freezer till analyzed. The steps were repeated upon completion of the six months intervention period.
Enzyme-linked immunosorbent assay (ELISA):
Serum samples were assayed using enzyme-linked immunosorbent assay (ELISA) multiplex kit according to the manufacturer guideline (R\&D System Human Magnetic Luminex Assay: LXSAHM-08).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Probiotic group
27 participants received probiotics twice daily for six months
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
Placebo group
25 participants received placebo twice daily for six months
Placebo
Placebo samples produced were identical to the probiotics in term of taste and texture without live microorganisms.
Interventions
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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
Placebo
Placebo samples produced were identical to the probiotics in term of taste and texture without live microorganisms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with colorectal cancer
* Planned for colorectal resection
Exclusion Criteria
* Consumed pro/pre/symbiotic product 2 weeks prior to recruitment,
* Patients with recurrent colorectal cancer
* Advanced metastasis
* Nursing or pregnant women
18 Years
ALL
No
Sponsors
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Dr. Liyana Zaharuddin
OTHER
Responsible Party
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Dr. Liyana Zaharuddin
Research Assistant Physiology Department, Faculty of Medicine
Principal Investigators
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Associate Professor Dr. Raja Affendi Raja Ali
Role: PRINCIPAL_INVESTIGATOR
Faculty Of Medicine, Universiti Kebangsaan Malaysia
References
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Zaharuddin L, Mokhtar NM, Muhammad Nawawi KN, Raja Ali RA. A randomized double-blind placebo-controlled trial of probiotics in post-surgical colorectal cancer. BMC Gastroenterol. 2019 Jul 24;19(1):131. doi: 10.1186/s12876-019-1047-4.
Other Identifiers
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TRGS/2/2014/UKM/02/3
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FPR.4/244/TRGS/2/2014/UKM/02/3
Identifier Type: -
Identifier Source: org_study_id