Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
Lactobacillus Fermentum
Placebo
Change in Low Anterior Resection Syndrome score from 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.
Time frame: Baseline to 8 weeks
Change in QoL(Quality of Life) score from Baseline to 8 weeks
Score 0-100(higher score means better outcome)
Time frame: Baseline to 8 weeks
Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis
Time frame: Baseline to 4, 8 weeks
Change of fecal metabolites assessed by fecal analysis
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
Time frame: Baseline to 4, 8 weeks
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