LARS - Low Anterior Resection Syndrome
Conditions
Keywords
LARS - Low Anterior Resection Syndrome, Probiotics, Colorectal Cancer
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.
Interventions
Lactobacillus Fermentum
DRUGPlacebo
Placebo
Sponsors
Premier Research
HEM Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis | Baseline to 4, 8 weeks | — |
| 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 |
Outcome results
None listed