HEM1036 Phase 2 Study in Low Anterior Resection Syndrome

NCT05527301 | Unknown Phase 2

• 1 other identifier: HEM_HEM1036_01
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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

Conditions

LARS - Low Anterior Resection Syndrome

Keywords

LARS - Low Anterior Resection Syndrome; Probiotics; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in QoL(Quality of Life) score from Baseline to 8 weeks

  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

  Baseline to 4, 8 weeks

Study Arms (2)

HEM1036 (Lactobacillus fermentum)

EXPERIMENTAL

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

Drug: Lactobacillus Fermentum

Placebo

PLACEBO COMPARATOR

2g Powder for BID oral administration

Drug: Placebo

Interventions

Lactobacillus Fermentum DRUG

Lactobacillus Fermentum

Also known as: HEM1036

HEM1036 (Lactobacillus fermentum)

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ≥18 and ≤75 years old.
• Diagnosed with rectal cancer and undergone sphincter preserving rectal resection surgery.
• Completed curative treatment (rectal resection, systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, radiotherapy, and stomy repairment) ≥6 months prior to Screening.
• Current LARS with a LARS score \>20 at Screening.
• An Eastern Cooperative Oncology Group score 0 or 1 at Screening.
• No evidence of anastomotic leakage or severe stenosis.
• 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.
• Capable of actively communicating with the investigator/study personnel and completing the study related documents.
• Body mass index is at least 18 kg/m2 but no more than 35 kg/m2.

You may not qualify if:

• History of: Abdominoperineal resection surgery, Hartmann operation, colostomy, Transanal irrigation therapy for LARS within 2 weeks prior to Screening, Secondary operation with stoma, etc.
• Not completed stomy repairment done at rectal resection surgery.
• History of allergic or adverse responses to IP or Milk, yeast, soy.
• On systemic chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or radiotherapy at the time of Screening.
• Any antibiotic use within 4 weeks before the first dose of the IP.
• 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.
• Tested positive for HIV antigen, Hepatitis B, C at screening
• Past or current alcohol or drug abuse history

Sponsors & Collaborators

• HEM Pharma Inc.: lead
• Premier Research: collaborator

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 2, 2022
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share