Probiotic Effects On Clinical and Circulating Inflammatory Cytokines Status In Patients With Colorectal Cancer: A Randomised Double Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Level of circulating inflammatory cytokines (TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL17C &IL-22) pre and post intervention.
研究概览
简要总结
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.
详细描述
BACKGROUND: The study aimed to determine effects of probiotic consumption containing six viable microorganisms of 3g x 1010 Lactobacillus and Bifidobacteria strains for six months on clinical outcomes and eight colorectal cancer related inflammatory cytokines level in patients with colorectal cancer. Among cytokines investigated were Tumour Necrosis Factor alpha (TNF- α), Interferon gamma (IFN-γ), Interleukin 6 (IL-6), Interleukin 10 (IL-10), Interleukin 12 (IL-12), Interleukin 17A (IL-17A), Interleukin 17-C (IL-17C) and Interleukin 22 (IL-22)
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
both probiotic and placebo product were labelled as either A or B and was given to the patients through simple randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and above.
- •Diagnosed with colorectal cancer
- •Planned for colorectal resection
排除标准
- •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
结局指标
主要结局
Level of circulating inflammatory cytokines (TNF-α, IFN-γ, IL-6, IL-10, IL-12, IL-17A, IL17C &IL-22) pre and post intervention.
时间窗: 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.
次要结局
- Number of patients with chemotherapy induced diarrhoea assessed by CTCAE v3.0(During the six month intervention period.)
研究者
Dr. Liyana Zaharuddin
Research Assistant Physiology Department, Faculty of Medicine
National University of Malaysia