Synergistic Immunomodulatory Effect of Synbiotics Pre and Postoperative Resection of Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Immunohistochemistry testing for immune cells infiltration and interferon-gamma expression
研究概览
简要总结
The goal of this interventional study was to evaluate the synergistic effect of symbiotics (a combination of probiotics and prebiotics) compared to probiotics alone in terms of their impact on anti-tumor immunomodulation in patients with pancreatic ductal adenocarcinoma (PDAC). The study also aimed to assess the effects of these interventions on postoperative complications and outcomes. In the study, a probiotic agent (Nowfoods, USA), containing ten strains of bacteria with a total dosage of 25 billion colony-forming units (CFU) was administered. This probiotic regimen involved taking two capsules once daily, starting two weeks before the surgery and continuing for one month after the surgery. For the synbiotic group, in addition to the probiotic agent, two capsules per day of inulin supplement (HERBAMAMA, USA) were also taken.
The study included three groups: the synbiotics group, the probiotics group, and the placebo group. The researchers compared the pathological status of immune cell infiltration (specifically CD8 cells) and interferon-gamma expression, as well as the levels of interleukins 10, 6, and 10 in the participants' serum. Four blood samples were collected from each participant: one taken 14 days before the surgery, one on the surgery date, one two weeks after the surgery, and one 30 days after the surgery.
The main research question addressed by the study was whether there was a significant difference in the immunomodulatory effect and postoperative complications between the synbiotics group and the probiotics group. The placebo group likely served as a control to compare the effects of the interventions against no intervention.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary PDAC with complete pathological and follow-up data
- •Patients without long-distance metastasis
- •Patients without chronic diseases
- •Patients without any treatments before the surgery.
排除标准
- •Patients who suffered from other tumors or other chronic diseases or accidentally died
- •Lack of pathological and follow-up data.
- •Patients with long-distance metastasis before the surgery.
结局指标
主要结局
Immunohistochemistry testing for immune cells infiltration and interferon-gamma expression
时间窗: IHC testing for formalin fixed paraffin embedded block for all subjects 10 months from the beginning of the study, as we collected the all samples
Change in the percentage of infiltrating CD8T cells in the tumor tissue as well as the interferon-gamma in synbiotics group
Post-operative -non-infectious complications- improvement
时间窗: 1-4 weeks post operative
Testing the percentage of subjects having Anastomotic Leakage, Diarrhea, Abdominal distension
Post-operative -infectious complications improvement
时间窗: 1-4 weeks post operative
Testing the percentage of subjects having Bacteremia, Wound infection, Pneumonia, Urinary tract infection
Inflammatory cytokines level
时间窗: 10 months after collection of all blood samples from included subjects
A change in the inflammatory cytokines levels (IL 10, IL6, and IL 1 β) in synbiotics-treated group with a significant difference rather the placebo and probiotics only treated groups
Post-operative improvement days
时间窗: first day post operative till 20 days
Number of days for first stool, stay in the hospital and return to usual activity
Statistical analysis of the results
时间窗: 11 months from the beginning of the study
To assess the significance of changes in the percentage of CD8 cells in the tissue in all subjected groups as well as the expression of Interferon-gamma protein. Also, the concentration of circulating cytokines including IL B, IL6, and IL 10. Data were analyzed using statistical software package (IBM-SPSS) version 23 software. Kolmogorov-Smirnov test showed that the raw data were normally distributed. One ANOVA was applied to study the effect of treatment on the studied parameters. Two-way ANOVA was applied to study the effect of time and treatment on the studied parameters. The least significant difference (LSD) test was used to illustrate the statistical differences among the experimental groups. Duncan's test was used to illustrate the homogeneity among the different intervals. Data is displayed as mean ± standard error of the mean.
次要结局
未报告次要终点
研究者
Maher Sara
Dr
Theodor Bilharz Research Institute