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Not yet recruitingNCT05527301Updated May 25, 2023

HEM1036 Phase 2 Study in Low Anterior Resection Syndrome

A Phase 2 interventional study of Lactobacillus Fermentum and Placebo in LARS - Low Anterior Resection Syndrome, sponsored by HEM Pharma Inc.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by HEM Pharma Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • LARS - Low Anterior Resection Syndrome

Keywords

  • LARS - Low Anterior Resection Syndrome
  • Probiotics
  • Colorectal Cancer
03

In context

Low Anterior Resection Syndrome

85 studies on the registry are indexed under Low Anterior Resection Syndrome; 36 are open to participants now.

This study's planned enrollment of 67 is close to the median of 67 across 57 interventional studies indexed under Low Anterior Resection Syndrome.

Browse Low Anterior Resection Syndrome studies →

Lead sponsor

This is the only study on the registry with HEM Pharma Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
67 participants (estimated)

Study arms

  • 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

    Drug: Lactobacillus Fermentum

  • Placebo comparator
    Placebo

    2g Powder for BID oral administration

    Drug: Placebo

Interventions

  • DrugLactobacillus Fermentum

    Lactobacillus Fermentum

    Also known as: HEM1036

  • DrugPlacebo

    Placebo

06

What researchers measure

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.

    Time frame: Baseline to 8 weeks

Secondary outcomes

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

    Score 0-100(higher score means better outcome)

    Time frame: Baseline to 8 weeks

  2. Change in fecal microbiota composition assessed by alpha-diversity and differential abundance analysis

    Time frame: Baseline to 4, 8 weeks

  3. 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

    Time frame: Baseline to 4, 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05527301
Lead sponsor
HEM Pharma Inc.
Collaborators
Premier Research Group plc
Responsible party
Sponsor
First posted
Sep 2, 2022
Start date
Jan 1, 2024 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
May 25, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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