Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG) (PROSALVAG)
Primary Purpose
Microbial Colonization, Dysbiosis, Fertility Issues
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
FertyBiotic Balance
Sponsored by
About this trial
This is an interventional supportive care trial for Microbial Colonization
Eligibility Criteria
Inclusion Criteria:
- Aged: 35-43 years old
- Vaginal pH > 4,5 and low Lactobacillus count or Nugent score of 4-6
- With interest in getting pregnant and ideally in IVF waiting list
- History of recurrent genitourinary infections
Exclusion Criteria:
- Any pathology that interferes with the study
- Current intake of food supplements or probiotics
- Current intake of contraceptives
- Use of oral or vaginal probiotics in the last 6 months
- Hypersensitivity to any of the components of the studied product
- Current vaginal infection
- Pregnant women
- Breastfeeding
- Use of intrauterine device
- Use of spermicide
- Use of cervical caps as hormonal therapy
Sites / Locations
- HM Fertility Centter VallésRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FertyBiotic Balance
Arm Description
Participants received FertyBiotic Balance one capsule a day
Outcomes
Primary Outcome Measures
Rectal and vaginal colonization
Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen
Secondary Outcome Measures
Autoinmune capacity
Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10
Antioxidant effect
Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05176535
Brief Title
Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)
Acronym
PROSALVAG
Official Title
Study to Determine Vaginal Colonization and Effect of an Oral Probiotic That Contains L.Rhamnosus, L. Plantarum and L. Crispatus in Women (PROSALVAG)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
October 11, 2022 (Anticipated)
Study Completion Date
March 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fertypharm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.
Detailed Description
After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing L. rhamnosus, L. plantarum and L. crispatus once daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization, Dysbiosis, Fertility Issues
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FertyBiotic Balance
Arm Type
Experimental
Arm Description
Participants received FertyBiotic Balance one capsule a day
Intervention Type
Dietary Supplement
Intervention Name(s)
FertyBiotic Balance
Intervention Description
Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209
Primary Outcome Measure Information:
Title
Rectal and vaginal colonization
Description
Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Autoinmune capacity
Description
Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10
Time Frame
10 weeks
Title
Antioxidant effect
Description
Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde
Time Frame
10 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Restoration of vaginal microbiota
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged: 35-43 years old
Vaginal pH > 4,5 and low Lactobacillus count or Nugent score of 4-6
With interest in getting pregnant and ideally in IVF waiting list
History of recurrent genitourinary infections
Exclusion Criteria:
Any pathology that interferes with the study
Current intake of food supplements or probiotics
Current intake of contraceptives
Use of oral or vaginal probiotics in the last 6 months
Hypersensitivity to any of the components of the studied product
Current vaginal infection
Pregnant women
Breastfeeding
Use of intrauterine device
Use of spermicide
Use of cervical caps as hormonal therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva González
Phone
+34 932 301 260
Email
egonzález@fertypharm.com
Facility Information:
Facility Name
HM Fertility Centter Vallés
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28801
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva González
Phone
+34 932 301 260
Email
egonzalez@fertypharm.com
12. IPD Sharing Statement
Learn more about this trial
Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)
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