HEM1036 Phase 2 Study in Low Anterior Resection Syndrome

NCT ID: NCT05527301

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-01-01

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.

Conditions

LARS - Low Anterior Resection Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HEM1036 (Lactobacillus fermentum)

Daily dose of 1 × 10\^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration

Group Type: EXPERIMENTAL

Lactobacillus Fermentum

Intervention Type: DRUG

Lactobacillus Fermentum

Placebo

2g Powder for BID oral administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Lactobacillus Fermentum

Lactobacillus Fermentum

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

HEM1036

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Premier Research Group plc

UNKNOWN

Sponsor Role: collaborator

HEM Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HEM_HEM1036_01

Identifier Type: -

Identifier Source: org_study_id