Clinical trial · Interventional
HEM1036 Phase 2 Study in Low Anterior Resection Syndrome
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)
NCT05527301CI-TRIAL-00066719unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Double-blind, randomized, placebo controlled phase 2 study to explore the efficacy and safety of HEM1036 in the treatment of subjects with LARS
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| LARS - Low Anterior Resection Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus Fermentum | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HEM1036 (Lactobacillus fermentum)
- description
- Daily dose of 1 × 10\^10 colony-forming units divided in 2 equal doses as a powder for BID oral administration
- interventionNames
- Drug: Lactobacillus Fermentum
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 2g Powder for BID oral administration
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change in Low Anterior Resection Syndrome score from Baseline to 8 weeks
- timeFrame
- Baseline to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.