HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
- Conditions
- LARS - Low Anterior Resection Syndrome
- Interventions
- Drug: Placebo
- Registration Number
- NCT05527301
- Lead Sponsor
- HEM Pharma Inc.
- Brief Summary
Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 67
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 2g Powder for BID oral administration HEM1036 (Lactobacillus fermentum) Lactobacillus Fermentum Daily dose of 1 × 10\^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration
- Primary Outcome Measures
Name Time Method Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in QoL(Quality of Life) score from Baseline to 8 weeks Baseline to 8 weeks Score 0-100(higher score means better outcome)
Change of fecal metabolites assessed by fecal analysis Baseline to 4, 8 weeks Change of metabolites (including Total short-chain fatty acids, acetate, butyrate,propionate, lactate, bile acids in fecal samples) assessed by fecal analysis and all parameters will be presented as umol/g
Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis Baseline to 4, 8 weeks