Colorectal Cancer Clinical Trial
Official title:
Probiotic Effects On Clinical and Circulating Inflammatory Cytokines Status In Patients With Colorectal Cancer: A Randomised Double Blind Clinical Trial
Verified date | December 2018 |
Source | National University of Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | November 26, 2018 |
Est. primary completion date | November 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Liyana Zaharuddin |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of circulating inflammatory cytokines (TNF-a, IFN-?, IL-6, IL-10, IL-12, IL-17A, IL17C &IL-22) pre and post 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. | Change from pre intervention baseline level at post six months intervention. | |
Secondary | Number of patients with chemotherapy induced diarrhoea assessed by CTCAE v3.0 | 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). | During the six month intervention period. |
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