Vaginal colonization of lactobacillus acidophilus and lacticaseibacillus rhamnosus in healthy females: a double-blind, randomized, placebo-controlled trial

Danisco Sweeteners Oy (Finland)0 个研究点目标入组 50 人开始时间: 2020年9月16日最近更新: 2023年3月6日

适应症

试验速览

•2. Age 18–50 years (fertile age)
•3. Caucasian
•4. No vaginal infections within the previous 6 months
•5. Has not participated in another investigational drug clinical trial within 1 month (30 days) or received an investigational drug within the last month (30 days) before the start of screening
•6. No significant changes in daily routines related to dietary/activity patterns
•7. Willingness to take dietary supplements
•8. Valid contraception for the duration of the study:
•8.1. Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy
•8.2. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
•8.3. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment.
•8.4. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject
•8.5. Barrier contraceptive (condoms)
•9. Willingness to collaboration in completing the binding parts of the study protocol

•1. Vaginal or urinary complaints within 3 months
•2. Vaginal pH > 4.5
•3. Pregnant or planning pregnancy
•4. Breastfeeding
•5. History of significant vulvo-vaginal pathological conditions
•6. Antibiotic usage during last 3 months
•7. Oral corticosteroid usage during last 3 months
•8. Use of vulvo-vaginal medication
•9. Acquired or congenital immune deficiency
•10. Recent history of radiotherapy (within 2 years)
•11. Current or prolonged (more than 1 month in last 2 years) use of corticosteroids or other immune modulating medication. Inhaled corticosteroids for asthma are not considered as an exclusion if their usage has begun more than 3 months prior to recruitment
•12. Habitual use of probiotic supplementation
•13. Menstrual irregularities including menopause
•14. On-going diagnosed disease which in the opinion of the investigator makes the participant unfit for the study
•15. Intolerance to any of the study products
•16. History of alcohol abuse within 2 years
•17. History of drug abuse within 2 years
•18. Unable to communicate with the investigator
•19. Positive culture from swabs at visit 1 or Nugent score >3 (added 05/01/2021)

发起方

Danisco Sweeteners Oy (Finland)