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

Sponsor
UAS Labs LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03543982
Collaborator
(none)
37
Enrollment
1
Location
1
Arm
33.8
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Oral probiotic product
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Pilot Study to Assess the Effects of an Oral Probiotic Product on the Vaginal Microbial Community and on Parameters of Vaginal Health
Actual Study Start Date :
May 23, 2018
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Mar 18, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oral probiotic product

Dietary Supplement: Oral probiotic product
Once per day (QD), 28 days

Outcome Measures

Primary Outcome Measures

  1. Changes in vaginal microbial community, via next generation sequencing. [Day 28]

Secondary Outcome Measures

  1. Changes in vaginal microbial community, via next generation sequencing. [Day 14 and 42]

  2. Changes in vaginal pH. [Day 14, 28 and 42]

  3. Changes in Nugent Score (Scale of 0 to 10). [Day 14, 28 and 42]

  4. Parameters of well-being, via Vulvovaginal Symptom Questionnaire. [Day 14, 28 and 42]

  5. Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events. [Day 14, 28 and 42]

  6. Compliance as assessed by capsule counts of the returned IP. [Day 14, 28 and 42]

Other Outcome Measures

  1. Colonization of the vaginal microbiome. [Day 14, 28 and 42]

  2. Colonization of the GI microbiome. [Day 14, 28 and 42]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Healthy women aged 18-50 years.

  2. Body mass index 18.5 - 34.9 kg/m2 (inclusive).

  3. Have childbearing potential [i.e. not surgically sterile or post-menopausal (greater than one year since last menses)].

  4. Non-smoker, or ex-smoker ≥6 months.

  5. Nugent score of 4-6 or pH >4.5

  6. Agrees to maintain current level of physical activity and dietary habits throughout the trial period.

  7. Agrees to discontinue use of probiotic supplements (oral or vaginal), as well as food supplemented with probiotics or prebiotics.

  8. Willing and able to provide written informed consent.

  9. Agrees to provide fecal samples during the trial period.

Exclusion Criteria:

  1. Hypersensitivity to any ingredient in the study product.

  2. Pregnancy or planning pregnancy.

  3. Lactation or breast feeding.

  4. Irregular menstrual cycles.

  5. Use of contraceptives that contain spermicidal agents.

  6. Use of an intrauterine device (IUD).

  7. Use of hormonal therapy through cervical cap.

  8. Use of douching devices.

  9. Any major trauma or surgical event within the 3 months prior to screening.

  10. Individuals undergoing therapies to prevent any recurrent infections.

  11. Allergy to any antibiotic that may be prescribed as a rescue remedy during the study.

  12. Use of prescription drugs (other than birth control) within 1 month prior to Visit 1.

  13. Use of antibiotics within 2 months prior to Visit 1.

  14. History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)

  15. Presence of systemic diseases or immunodeficiencies

  16. Abdominal or gastrointestinal surgery within the previous 12 months.

  17. Recent gastrointestinal food-borne illness (within 1 month prior to Visit 1)

  18. History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years

  19. Abnormal laboratory test results of clinical significance

  20. Presence or history (past 6 months) of alcohol or drug abuse

  21. Subject is unwilling or unable to abide by the requirements of the protocol

  22. Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk

  23. Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nutrasource Guelph Ontario Canada N1G 0B4

Sponsors and Collaborators

  • UAS Labs LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
UAS Labs LLC
ClinicalTrials.gov Identifier:
NCT03543982
Other Study ID Numbers:
  • UAS1RPD-160001-PRVH
First Posted:
Jun 1, 2018
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 8, 2021