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Trial Title:
HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
NCT ID:
NCT05527301
Condition:
LARS - Low Anterior Resection Syndrome
Conditions: Official terms:
Low Anterior Resection Syndrome
Syndrome
Conditions: Keywords:
LARS - Low Anterior Resection Syndrome
Probiotics
Colorectal Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Lactobacillus Fermentum
Description:
Lactobacillus Fermentum
Arm group label:
HEM1036 (Lactobacillus fermentum)
Other name:
HEM1036
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
January 1, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
HEM Pharma Inc.
Agency class:
Industry
Collaborator:
Agency:
Premier Research Group plc
Agency class:
Industry
Source:
HEM Pharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527301
