Effect of lactic acid bacteria Rosell-11&52 on vaginal bacterial flora

JRCT ID: jRCT1030210147

Registered date:14/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Improvement of vaginal bacterial flora
• Date of first enrollment: 02/11/2021
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Take 3 "lactic acid bacteria Rosell-11&52" daily, in principle, after each meal. If you cannot take it after each meal, you may take it all at once.

Outcome(s)

• Primary Outcome: Balance of vaginal flora
• Secondary Outcome: Subjective symptoms related to vaginal discharge (smelling, graying, smoothness, etc.) and subjective symptoms such as mild itching and swelling in the vulva (questionnaire)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Female

Include criteria

Those who voluntarily express their participation in the examination and who meet the following selection criteria and do not violate the exclusion criteria are eligible.
(1) Women who have menstruation between the ages of 20 and 50 at the time of obtaining consent
(2) Those who can cooperate with the pre-questionnaire
(3) Receive an explanation of the clinical trial in advance, understand the content, agree with the purpose, and obtain the written consent of the person.

Exclude criteria

(1) Those who are going to the hospital due to uterine and vaginal diseases
(2) Those who are taking antibiotics and antibacterial agents (within 1 month)
(3) Those who are taking hormones
(4) Those who are breastfeeding
(5) Those who are taking lactic acid bacteria / lactoferrin supplements (within 1 month)
(6) Persons with a history of serious illnesses such as heart, liver, kidneys, digestive organs, etc.
(7) Heavy alcohol drinkers
(8) Persons with extremely irregular eating habits, persons with irregular life rhythms such as shift workers and late-night workers
(9) Those who are allergic to drugs and foods
(10) Those who are participating in clinical trials of other medicines or health foods, those who are within 4 weeks after the end of the trial, or those who plan to participate in other clinical trials after consenting to participate in this trial.
(11) Others who are judged to be inappropriate for this test
(12) Persons who work for cosmetics, pharmaceuticals, and hygiene products companies in person or in the family

Related Information

• Primary Sponsor: Endo Toshiaki