Vaginal colonization by orally consumed lactobacilli in healthy wome

Not Applicable

Completed

• Conditions: Vaginal health; Urological and Genital Diseases

• Registration Number: ISRCTN29375062
• Lead Sponsor: Danisco Sweeteners Oy (Finland)

Brief Summary

2023 Results article in https://doi.org/10.3390/microorganisms11020499 (added 21/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-16
• Study Completion: 2021-03-24
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Female
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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal colonization of L. acidophilus and L. rhamnosus measured with quantitative PCR at baseline, day 7, day 14 and day 21

Secondary Outcome Measures

Name	Time	Method
<br> Vaginal pH measured with pH test strips baseline, day 7, day 14 and day 21<br><br> Exploratory analyses include assessment of vaginal microbiota composition and immunological markers<br>