Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

BioLeaders

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Drug: BLS_ILB_710c 1000mg; Drug: BLS_ILS_E710c 1500mg; Drug: BLS_ILS_E710c 500mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195089

12591 (Other Identifier)

UMT2013-BLS-ILB-E710c

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).

Full description

This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte.

The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation

Enrollment: 19 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-menopausal patients between age of 20 and 50.
• Patients with cervical intraepithelial neoplasia 3(CIN3).
• Only infection with HPV type 16.
• Patients with Capable of observation of all of lesions by Colposcopy biopsy.
• Be informed of the nature of the study and will give written informed consent.
• Be agree with contraception during study
• White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 /mm^3
• Normal for EKG(Electrocardiography)
• AST/ALT : 2.5 times less than normal range

Exclusion criteria

• Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive.
• Patient that has medical history of hypersensitivity about Food containing Lactic acid bacteria or Lactic acid bacteria medication.
• Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage, meningitis etc.)
• Investigational product within three months before the start of the drug administration to patients treated with other test drug.
• Patient with Chronic pancreatitis currently or Patients diagnosed with acute pancreatitis.
• Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal tumors, ulcers, bleeding, perforation etc.
• Pregnant or lactating women
• Patient with HBV or HCV infection (except for Asymptomatic)
• Patient that Investigator judge
• Deemed inappropriate for researchers to judge the patient

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

BLS_ILB_E710c 500mg

Experimental group

Description:

* Drug: BLS_ILB_E710c 500mg * Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 \& 8)

Treatment:

Drug: BLS_ILS_E710c 500mg

BLS_ILS_E710c 1000mg

Experimental group

Description:

* Drug: BLS_ILS_E710c 1000mg * Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 \& 8)

Treatment:

Drug: BLS_ILB_710c 1000mg

BLS_ILS_E710c 1500mg

Experimental group

Description:

* Drug: BLS_ILS_E710c 1500mg * Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 \& 8)

Treatment:

Drug: BLS_ILS_E710c 1500mg