Clinical trial NCT05527301: HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: LARS - Low Anterior Resection Syndrome
Keywords: LARS - Low Anterior Resection Syndrome
Probiotics
Colorectal Cancer
Lead sponsor: HEM Pharma Inc.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2022-09-02
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male and female subjects ≥18 and ≤75 years old.
2. Diagnosed with rectal cancer and undergone sphincter preserving rectal resection surgery.
3. Completed curative treatment (rectal resection, systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, radiotherapy, and stomy repairment) ≥6 months prior to Screening.
4. Current LARS with a LARS score \>20 at Screening.
5. An Eastern Cooperative Oncology Group score 0 or 1 at Screening.
6. No evidence of anastomotic leakage or severe stenosis.
7. 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.
8. Capable of actively communicating with the investigator/study personnel and completing the study related documents.
9. Body mass index is at least 18 kg/m2 but no more than 35 kg/m2.

Exclusion Criteria:

1. History of: Abdominoperineal resection surgery, Hartmann operation, colostomy, Transanal irrigation therapy for LARS within 2 weeks prior to Screening, Secondary operation with stoma, etc.
2. Not completed stomy repairment done at rectal resection surgery.
3. History of allergic or adverse responses to IP or Milk, yeast, soy.
4. On systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or radiotherapy at the time of Screening.
5. Any antibiotic use within 4 weeks before the first dose of the IP.
6. 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.
7. Tested positive for HIV antigen, Hepatitis B, C at screening
8. Past or current alcohol or drug abuse history

Primary outcomes:
measure: Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in QoL(Quality of Life) score from Baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis
timeFrame: Baseline to 4, 8 weeks
measure: Change of fecal metabolites assessed by fecal analysis
timeFrame: Baseline to 4, 8 weeks
Other outcomes:
Locations:
Study officials:
References: