HEM1036 Phase 2 Study in Low Anterior Resection Syndrome

HEM Pharma

Status and phase: Not yet enrolling; Phase 2

Conditions: LARS - Low Anterior Resection Syndrome

Treatments: Drug: Placebo; Drug: Lactobacillus Fermentum

Study type: Interventional

Funder types: Industry

Identifiers

NCT05527301

HEM_HEM1036_01

Details and patient eligibility

About

Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS

Full 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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

HEM1036 (Lactobacillus fermentum)

Experimental group

Description:

Daily dose of 1 × 10\^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration

Treatment:

Drug: Lactobacillus Fermentum

Placebo

Placebo Comparator group

Description:

2g Powder for BID oral administration

Treatment:

Drug: Placebo