LARS - Low Anterior Resection SyndromePhase 2NCT05527301
HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
A Phase 2 study testing Lactobacillus Fermentum in people with LARS - Low Anterior Resection Syndrome, run by HEM Pharma Inc..
Trial summary
Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- LARS - Low Anterior Resection Syndrome
- What is being tested?
- Lactobacillus Fermentum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
About this study
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)
Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS
Read the 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
- Being tested
- Lactobacillus Fermentum, Placebo
- Keywords
- LARS - Low Anterior Resection Syndrome, Probiotics, Colorectal Cancer
- Medical subject headings
- Low Anterior Resection Syndrome, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus FermentumDrug
Also called HEM1036
Lactobacillus Fermentum
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lactobacillus Fermentum |
| Placebo | Placebo comparator | 2g Powder for BID oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Secondary outcomes (3)
Change in QoL(Quality of Life) score from Baseline to 8 weeks
Score 0-100(higher score means better outcome)
Measured: Baseline to 8 weeks
Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis
Measured: 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
Measured: Baseline to 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LARS - Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HEM Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527301
- Sponsor's protocol ID
- HEM_HEM1036_01
- Status last verified
- May 2023
- First submitted
- 8 Aug 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05527301
- Acronym / sponsor ID
- HEM_HEM1036_01
- Conditions
- LARS - Low Anterior Resection Syndrome
- Keywords
- LARS - Low Anterior Resection Syndrome, Probiotics, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- HEM Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEM1036 (Lactobacillus fermentum) | Experimental | Drug: Lactobacillus FermentumDaily dose of 1 × 10^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration |
| Placebo | Placebo comparator | Drug: Placebo2g Powder for BID oral administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus FermentumAlso: HEM1036Lactobacillus Fermentum | Drug | HEM1036 (Lactobacillus fermentum) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks
Time frame: 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.
3 secondary outcomes
Change in QoL(Quality of Life) score from Baseline to 8 weeks
Time frame: Baseline to 8 weeks
Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis
Time frame: Baseline to 4, 8 weeks
Change of fecal metabolites assessed by fecal analysis
Time frame: Baseline to 4, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus Fermentum in people with LARS - Low Anterior Resection Syndrome, run by HEM Pharma Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.