CTRI/2026/02/104267尚未招募不适用
A Multicentric, Prospective, Observational Study to Evaluate the Real World Effectiveness and Safety of Probiotic Supplementation with Lobun Forte in Patients with Chronic Kidney Disease in India.
J. B. chemicals & pharmaceuticals LTD.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
研究概览
简要总结
This is a Multicentric, Prospective, Observational Study to Evaluate the Real-World Effectiveness and Safety of Probiotic Supplementation with Lobun Forte in Patients with Chronic Kidney Disease in India. The primary objective of the study is to assess the effectiveness of Probiotic Supplementation with Lobun Forte, measured by the mean change in BUN from baseline to end of treatment. The secondary objective is to evaluate the safety of the investigational product. Approximately 200 patients are expected to be enrolled. Data collection will include demographic information, medical history, clinical symptoms, treatment details, and adverse events.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 years and above with a confirmed diagnosis of CKD Stage III and IV.
- •2.Patients with stable CKD management for at least two weeks prior to enrolling in the study.
- •3.Patients prescribed Lobun Forte alongside standard treatment for at least 12 weeks.
- •4.Patients willing to attend a follow-up visit at the end of 6 weeks and after 12 weeks.
排除标准
- •1.Patients undergoing haemodialysis.
- •2.Patients with acute kidney injury or a recent renal transplant.
- •3.Patients requiring hospitalization during the study period.
- •4.Pregnant or lactating women.
- •5.Patients receiving any other probiotic therapy or who have used probiotics in the last 1 week.
- •6.Patients with a history of allergic reaction to probiotics or any component of Lobun Forte.
研究者
Dr Kapil Mehta
J. B. chemicals & pharmaceuticals LTD.
研究点 (2)
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