The Effect of Administering the Probiotic Lactiplantibacillus Plantarum DAD-13 on Procalcitonin Levels, C-Reactive Protein, and Interleukin-6 in Sepsis Patients in the Intensive Care Unit of H. Adam Malik Hospital, Medan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Procalcitonin (PCT) levels in ICU sepsis patients after probiotic administration
研究概览
简要总结
This study investigated whether giving the probiotic Lactiplantibacillus plantarum DAD-13 to sepsis patients in the intensive care unit (ICU) could help reduce inflammation and improve bowel function. A total of 30 adult ICU patients with sepsis were randomly assigned to receive either the probiotic or a placebo for four days, along with standard treatment. Blood tests were performed to measure inflammatory markers, including procalcitonin (PCT), C-reactive protein (CRP), and interleukin-6 (IL-6), before and after the treatment. The study also observed defecation frequency and stool consistency. Results showed a clinical trend toward lower inflammation levels in the probiotic group and significantly better bowel function. The findings suggest that this probiotic may support immune response and gut health in sepsis patients, although more research is needed to confirm these results.
详细描述
This randomized controlled trial aimed to evaluate the potential benefits of the probiotic Lactiplantibacillus plantarum DAD-13 in adult ICU patients diagnosed with sepsis. The primary objective was to assess the probiotic's effect on systemic inflammation and gastrointestinal function. A total of 30 patients were randomly divided into two groups: one group received the probiotic preparation for four days in addition to standard sepsis management, while the other group received a placebo with the same treatment duration.
Inflammatory biomarkers such as procalcitonin (PCT), C-reactive protein (CRP), and interleukin-6 (IL-6) were measured before and after the intervention to evaluate immune and inflammatory responses. In addition, clinical observations were conducted on bowel movement frequency and stool consistency to assess bowel function.
The results indicated a trend toward reduced levels of inflammatory markers in the probiotic group compared to the placebo group. Moreover, patients who received the probiotic exhibited improved bowel function, including more regular defecation and better stool consistency. These findings support the hypothesis that Lactiplantibacillus plantarum DAD-13 may contribute to reducing inflammation and enhancing gut health in critically ill sepsis patients. However, due to the limited sample size, further studies are warranted to confirm the clinical significance and safety of this intervention in broader patient populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcomes assessors were all blinded to treatment group assignments throughout the study to prevent bias.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Diagnosed with sepsis based on clinical and laboratory criteria.
- •Admitted to ICU.
- •Receiving enteral nutrition (1500-2000 kcal/day) via nasogastric tube.
- •Able to provide or have proxy informed consent.
排除标准
- •History of gastrointestinal disease.
- •Immunocompromised condition (e.g., HIV, chemotherapy).
- •Presence of intravascular devices.
- •Known allergy to probiotics.
- •Concurrent participation in other clinical trials
研究组 & 干预措施
Placebo Group
Participants in this arm received placebo capsules containing maltodextrin via NGT, identical in appearance and schedule to the probiotic group (2 capsules/day for 4 days), alongside standard sepsis care.
干预措施: Lactiplantibacillus plantarum DAD-13 (Dietary Supplement)
Placebo Group
Participants in this arm received placebo capsules containing maltodextrin via NGT, identical in appearance and schedule to the probiotic group (2 capsules/day for 4 days), alongside standard sepsis care.
干预措施: Placebo (Drug)
Dietary Supplement: Lactiplantibacillus plantarum DAD-13
The probiotic supplement Lactiplantibacillus plantarum DAD-13 was given in capsule form (2 capsules/day) via NGT for 4 days. Each capsule contains a standardized dose of viable bacteria formulated to modulate immune response and gut flora.
干预措施: Lactiplantibacillus plantarum DAD-13 (Dietary Supplement)
Dietary Supplement: Lactiplantibacillus plantarum DAD-13
The probiotic supplement Lactiplantibacillus plantarum DAD-13 was given in capsule form (2 capsules/day) via NGT for 4 days. Each capsule contains a standardized dose of viable bacteria formulated to modulate immune response and gut flora.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Procalcitonin (PCT) levels in ICU sepsis patients after probiotic administration
时间窗: Day 1 (T0) to Day 4 (T1) of intervention
This outcome assesses the change in Procalcitonin (PCT) levels from baseline (day 1) to day 4 in patients with sepsis who receive Lactiplantibacillus plantarum DAD-13 or placebo. PCT is a biomarker used to evaluate the severity of systemic inflammation and response to treatment in sepsis.
次要结局
未报告次要终点