Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05527301




Registration number
NCT05527301
Ethics application status
Date submitted
8/08/2022
Date registered
2/09/2022
Date last updated
25/05/2023

Titles & IDs
Public title
HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
Scientific 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)
Secondary ID [1] 0 0
HEM_HEM1036_01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
LARS - Low Anterior Resection Syndrome 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lactobacillus Fermentum
Treatment: Drugs - Placebo

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

Placebo Comparator: Placebo - 2g Powder for BID oral administration


Treatment: Drugs: Lactobacillus Fermentum
Lactobacillus Fermentum

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks
Timepoint [1] 0 0
Baseline to 8 weeks
Secondary outcome [1] 0 0
Change in QoL(Quality of Life) score from Baseline to 8 weeks
Timepoint [1] 0 0
Baseline to 8 weeks
Secondary outcome [2] 0 0
Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis
Timepoint [2] 0 0
Baseline to 4, 8 weeks
Secondary outcome [3] 0 0
Change of fecal metabolites assessed by fecal analysis
Timepoint [3] 0 0
Baseline to 4, 8 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
67
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
HEM Pharma Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Premier Research Group plc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05527301
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05527301