임상연구정보서비스

Search: Search

A 12 week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MED-01 on Vaginal Health

Status Approved

First Submitted Date

2020/12/18
Registered Date

2021/02/09
Last Updated Date

2020/12/18

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005881
Unique Protocol ID	HKS 2020-09-005
Public/Brief Title	A Clinical Trial for the Evaluation of the Efficacy and Safety of MED-01 on Vaginal Health
Scientific Title	A 12 week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of MED-01 on Vaginal Health
Acronym	MEDIOGEN_MED-01
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	HKS 2020-09-005-001
Approval Date	2020-10-21
Institutional Review Board Name	Hallym University Medical Center Gangnam Hospital IRB
Institutional Review Board Address	1, Singil-ro, Yeongdeungpo-gu, Seoul
Institutional Review Board Telephone	02-829-5527
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	sungho park
Title	Professor
Telephone	+82-2-6960-1200
Affiliation	Hallym University Medical Center-Kangnam
Address	1, Singil-ro, Yeongdeungpo-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	sungtaek park
Title	Associate Professor
Telephone	+82-2-6960-1200
Affiliation	Hallym University Medical Center-Kangnam
Address	1, Singil-ro, Yeongdeungpo-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	sungtaek park
Title	Associate Professor
Telephone	+82-2-6960-1200
Affiliation	Hallym University Medical Center-Kangnam
Address	1, Singil-ro, Yeongdeungpo-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-12-23 Anticipated
Target Number of Participant	100
Primary Completion Date	2021-07-31 , Anticipated
Study Completion Date	2021-08-31 , Anticipated
Name of Study	Hallym University Medical Center-Kangnam
Recruitment Status	Recruiting
Date of First Enrollment	2020-12-23 ,
Recruitment Status by Participating Study Site 2
Name of Study	Chung-Ang Univerisity Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-30 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Mediogen
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Mediogen
Organization Type	Others

7. Study Summary

Study Summary Information
Lay Summary	MED-01 is a complex of Lactobacillus salivarius MG242, Lactobacillus fermentum MG901, Lactobacillus plantarum MG989, Lactobacillus paracasei MG4272, and Lactobacillus rhamnosus MG4288 isolated from the vagina of Korean women. It is also listed in the Food Ingredients DB, and is secured as it is listed in the European Qualified Presumption of Safety (QPS) List and Canada's Natural Health Products Ingredients Database. In addition, through cell experiments, it was confirmed that the five Lactobacillus species that consist of MED-01 have the effect of inhibiting the growth and adhesion of vaginitis-causing bacteria. It was confirmed that MPO activity and inflammatory cytokine were significantly reduced. Therefore, this human application test is to evaluate the efficacy and safety on vaginal health when ingesting MED-01 (MED-01 probiotics) in women of childbearing age over 19 years and under 50 years old compared to the control food (Placebo) Planned for.

Study Summary Information

Lay Summary

MED-01 is a complex of Lactobacillus salivarius MG242, Lactobacillus fermentum MG901, Lactobacillus plantarum MG989, Lactobacillus paracasei MG4272, and Lactobacillus rhamnosus MG4288 isolated from the vagina of Korean women. It is also listed in the Food Ingredients DB, and is secured as it is listed in the European Qualified Presumption of Safety (QPS) List and Canada&#39;s Natural Health Products Ingredients Database.
In addition, through cell experiments, it was confirmed that the five Lactobacillus species that consist of MED-01 have the effect of inhibiting the growth and adhesion of vaginitis-causing bacteria. It was confirmed that MPO activity and inflammatory cytokine were significantly reduced.
Therefore, this human application test is to evaluate the efficacy and safety on vaginal health when ingesting MED-01 (MED-01 probiotics) in women of childbearing age over 19 years and under 50 years old compared to the control food (Placebo) Planned for.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	Intervention group: MED-01 probiotics 500mg capsule once a day Placebo group: placebo 500mg capsule once a day
Number of Arms	2
Arm 1	Arm Label Intervention group
	Target Number of Participant 50
	Arm Type Experimental
	Arm Description Intervention group: MED-01 probiotics 500mg capsule once a day
Arm 2	Arm Label Placebo group
	Target Number of Participant 50
	Arm Type Placebo comparator
	Arm Description Placebo group: placebo 500mg capsule once a day

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N89.9)Noninflammatory disorder of vagina, unspecified Womens Health
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 19Year~50Year
	Description 1) Women of childbearing age over 19 years of age and under 50 years of age 2) A person with a score of 4-6 on the Nugent core. 3) A person who agrees to participate in the human application test before the human application test begins and has prepared the written consent form.
Exclusion Criteria	1) Those who are currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease and malignant tumor (however, considering the condition of the human subject You can participate in the test at the discretion of the tester.) 2) The subjects who treated for vaginal or urinary tract infection as of Visit 1 3) The subjects with vaginal bleeding, abnormal vaginal secretion, or urinary system abnormality as of the standard of Visit1 4) The subjects who has been given antibiotics, antibacterial agents, steroids, and immunosuppressants within two weeks of visiting1 5) The subjects who has ingested health functional foods, probiotics, and lactobacillus products continuously (more than four times a week) within two weeks of visiting 1 6) A person who has received acupuncture treatment for women's cleanser, vaginal cleanser, sedentary treatment and vaginal health within one week of visiting 1 7) The subjects with unregulated hypertension (measuring standard after 10 minutes stabilization of the person subject to human application test) (above 160mmHg of blood pressure in the retractor or 100mmHg of blood pressure in the retractor). 8) Unregulated diabetics (if HbA1C exceeds 6.5%) 9) The subjects whose creatine is more than twice the normal limit of the testing agency 10) The subjects whose AST (GOT) or ALT (GPT) is at least three times the normal limit of the testing agency 11) The subjects whose TSH is less than 0.1 UU/ml or greater than 10 μU/ml 12) The subjects who are sensitive or allergic to the ingredients of this human-applied test food; 13) The subjects who is pregnant, breast-feeding, or planning to conceive within three months. 14) The subjects who has participated in another interventional clinical trial (including a human application test) within one month of the commencement of this human application test or who has a plan to participate in another interventional clinical trial (including a human application test) after the commencement of this human application test. 15) The subjects who is deemed inappropriate by the human application test testers for this human application test.
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Nugent Score
Timepoint	Visit1, Visit3, Visit4
Secondary Outcome(s) 1
Outcome	Vaginal pH
Timepoint	Visit1, Visit3, Visit4
Secondary Outcome(s) 2
Outcome	Vaginal microflora
Timepoint	Visit1, Visit3, Visit4
Secondary Outcome(s) 3
Outcome	Symptom Survey Assessment
Timepoint	Visit1, Visit3, Visit4

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top