Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health

NCT03543982 | Completed

• 1 other identifier: UAS1RPD-160001-PRVH
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.

Conditions

Vaginal Health

Outcome Measures

Primary Outcomes (1)

• Changes in vaginal microbial community, via next generation sequencing.

  Day 28

Secondary Outcomes (6)

• Changes in vaginal microbial community, via next generation sequencing.

  Day 14 and 42

• Changes in vaginal pH.

  Day 14, 28 and 42

• Changes in Nugent Score (Scale of 0 to 10).

  Day 14, 28 and 42

• Parameters of well-being, via Vulvovaginal Symptom Questionnaire.

  Day 14, 28 and 42

• Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events.

  Day 14, 28 and 42

Other Outcomes (2)

• Colonization of the vaginal microbiome.

  Day 14, 28 and 42

• Colonization of the GI microbiome.

  Day 14, 28 and 42

Study Arms (1)

Oral probiotic product

EXPERIMENTAL

Dietary Supplement: Oral probiotic product

Interventions

Oral probiotic product DIETARY_SUPPLEMENT

Once per day (QD), 28 days

Oral probiotic product

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women aged 18-50 years.
• Body mass index 18.5 - 34.9 kg/m2 (inclusive).
• Have childbearing potential \[i.e. not surgically sterile or post-menopausal (greater than one year since last menses)\].
• Non-smoker, or ex-smoker ≥6 months.
• Nugent score of 4-6 or pH \>4.5
• Agrees to maintain current level of physical activity and dietary habits throughout the trial period.
• Agrees to discontinue use of probiotic supplements (oral or vaginal), as well as food supplemented with probiotics or prebiotics.
• Willing and able to provide written informed consent.
• Agrees to provide fecal samples during the trial period.

You may not qualify if:

• Hypersensitivity to any ingredient in the study product.
• Pregnancy or planning pregnancy.
• Lactation or breast feeding.
• Irregular menstrual cycles.
• Use of contraceptives that contain spermicidal agents.
• Use of an intrauterine device (IUD).
• Use of hormonal therapy through cervical cap.
• Use of douching devices.
• Any major trauma or surgical event within the 3 months prior to screening.
• Individuals undergoing therapies to prevent any recurrent infections.
• Allergy to any antibiotic that may be prescribed as a rescue remedy during the study.
• Use of prescription drugs (other than birth control) within 1 month prior to Visit 1.
• Use of antibiotics within 2 months prior to Visit 1.
• History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
• Presence of systemic diseases or immunodeficiencies

Sponsors & Collaborators

• UAS Labs LLC: lead

Study Sites (1)

Nutrasource

Guelph, Ontario, N1G 0B4, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: June 1, 2018
• Study Start: May 23, 2018
• Primary Completion: October 1, 2020
• Study Completion: March 18, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CA (1)