NCT05527301

HEM1036 Phase 2 Study in Low Anterior Resection Syndrome

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: HEM Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• LARS - Low Anterior Resection Syndrome

Interventions

Type	Name	Description
DRUG	Lactobacillus Fermentum	Lactobacillus Fermentum
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-09-02
• Last updated: 2023-05-25