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)

Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS

Study Overview

• Status: Not yet recruiting
• Conditions: LARS - Low Anterior Resection Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Lactobacillus Fermentum

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.

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEM1036 (Lactobacillus fermentum); Daily dose of 1 × 10^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration	Drug: Lactobacillus Fermentum; Lactobacillus Fermentum; Other Names: HEM1036
Placebo Comparator: Placebo; 2g Powder for BID oral administration	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in QoL(Quality of Life) score from Baseline to 8 weeks	Score 0-100(higher score means better outcome)	Baseline to 8 weeks
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	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	Baseline to 4, 8 weeks

Collaborators and Investigators

• Sponsor: HEM Pharma Inc.
• Collaborators: Premier Research Group plc

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Probiotics; Colorectal Cancer; LARS - Low Anterior Resection Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Syndrome; Low Anterior Resection Syndrome
• Other Study ID Numbers: HEM_HEM1036_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No