Back to resultsHEM1036 Phase 2 Study in Low Anterior Resection Syndrome
Primary Purpose
LARS - Low Anterior Resection Syndrome
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lactobacillus Fermentum
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for LARS - Low Anterior Resection Syndrome focused on measuring LARS - Low Anterior Resection Syndrome, Probiotics, Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HEM1036 (Lactobacillus fermentum)
Placebo
Arm Description
Daily dose of 1 × 10^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration
2g Powder for BID oral administration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in QoL(Quality of Life) score from Baseline to 8 weeks
Score 0-100(higher score means better outcome)
Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis
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
Full Information
NCT ID
NCT05527301
First Posted
August 8, 2022
Last Updated
May 23, 2023
Sponsor
HEM Pharma Inc.
Collaborators
Premier Research Group plc
1. Study Identification
Unique Protocol Identification Number
NCT05527301
Brief Title
HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HEM Pharma Inc.
Collaborators
Premier Research Group plc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LARS - Low Anterior Resection Syndrome
Keywords
LARS - Low Anterior Resection Syndrome, Probiotics, Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HEM1036 (Lactobacillus fermentum)
Arm Type
Experimental
Arm Description
Daily dose of 1 × 10^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2g Powder for BID oral administration
Intervention Type
Drug
Intervention Name(s)
Lactobacillus Fermentum
Other Intervention Name(s)
HEM1036
Intervention Description
Lactobacillus Fermentum
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks
Description
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
Secondary Outcome Measure Information:
Title
Change in QoL(Quality of Life) score from Baseline to 8 weeks
Description
Score 0-100(higher score means better outcome)
Time Frame
Baseline to 8 weeks
Title
Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis
Time Frame
Baseline to 4, 8 weeks
Title
Change of fecal metabolites assessed by fecal analysis
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
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