A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of HEM1036 in Subjects With Low Anterior Resection Syndrome (LARS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 67
- 主要终点
- Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks
研究概览
简要总结
Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS
详细描述
The study will be conducted as a double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS. Subjects will be males and females ≥18 and ≤75 years of age with LARS. Subjects must have a LARS score of >20 at the Screening Visit after sphincter preserving rectal resection surgery for the curative treatment of diagnosed rectal cancer.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ≥18 and ≤75 years old.
- •Diagnosed with rectal cancer and undergone sphincter preserving rectal resection surgery.
- •Completed curative treatment (rectal resection, systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, radiotherapy, and stomy repairment) ≥6 months prior to Screening.
- •Current LARS with a LARS score >20 at Screening.
- •An Eastern Cooperative Oncology Group score 0 or 1 at Screening.
- •No evidence of anastomotic leakage or severe stenosis.
- •Capable of returning to study site for all study visits according to requirement of protocol and willing to comply with the policy, procedure, and restriction of the study.
- •Capable of actively communicating with the investigator/study personnel and completing the study related documents.
- •Body mass index is at least 18 kg/m2 but no more than 35 kg/m2.
排除标准
- •History of: Abdominoperineal resection surgery, Hartmann operation, colostomy, Transanal irrigation therapy for LARS within 2 weeks prior to Screening, Secondary operation with stoma, etc.
- •Not completed stomy repairment done at rectal resection surgery.
- •History of allergic or adverse responses to IP or Milk, yeast, soy.
- •On systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or radiotherapy at the time of Screening.
- •Any antibiotic use within 4 weeks before the first dose of the IP.
- •Is currently participating or has participated in another study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of the IP.
- •Tested positive for HIV antigen, Hepatitis B, C at screening
- •Past or current alcohol or drug abuse history
研究组 & 干预措施
HEM1036 (Lactobacillus fermentum)
Daily dose of 1 × 10^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration
干预措施: Lactobacillus Fermentum (Drug)
Placebo
2g Powder for BID oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks
时间窗: Baseline to 8 weeks
* Higher score means worse outcome * We will assess the change of LARS score at 8 weeks frome baseline. The change of LARS score of two treatment groups will be compared.
次要结局
- Change in QoL(Quality of Life) score from Baseline to 8 weeks(Baseline to 8 weeks)
- Change of fecal metabolites assessed by fecal analysis(Baseline to 4, 8 weeks)
- Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis(Baseline to 4, 8 weeks)