Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-24
Brief Title:
Randomized Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository
Sponsor:
Seed Health
Organization:
Seed Health
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial to Assess The Overall User Experience of a Synbiotic Vaginal Suppository
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the impact of a personal care product on vaginal health in individuals with a self-reported history of vaginal discomforts such as malodor bothersome discharge itching irritation and dryness The personal care product VH-01 contains a prebiotic and three distinct strains of Lactobacillus crispatus a microbe commonly found in healthy vaginal microbiomes The study will be a randomized placebo-controlled trial where the test product will be compared to a placebo in a 21 manner Participants will be asked to complete online questionnaires and provide vaginal samples to assess microbial communities
The aims of this study are to assess
1 The user experience and acceptability of VH-01 vaginal suppository vs placebo
2 Attitudes and perceptions of VH-01 vaginal suppository usage vs placebo
3 Health-related quality of life during the use of VH-01 vaginal suppository vs placebo
4 Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs placebo
The aims of this study are to assess
1 The user experience and acceptability of VH-01 vaginal suppository vs placebo
2 Attitudes and perceptions of VH-01 vaginal suppository usage vs placebo
3 Health-related quality of life during the use of VH-01 vaginal suppository vs placebo
4 Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs placebo
Detailed Description:
The vaginal microbiome is a community of microorganisms that live inside of the vagina Studies have shown that vaginal microbiomes can be classified into one of five community state types CSTs known as CST I II III IV and V CSTs are determined based on the taxonomic composition of the vaginal microbiome CST I dominated by Lactobacillus crispatus is considered optimal and is significantly associated with vaginal health
Lactobacillus crispatus produces lactic acid and other compounds that maintain an optimal vaginal pH which discourages the growth of harmful microbes that lead to disruptions in the vaginal microbial ecosystem These disruptions may increase vaginal discomforts such as vaginal malodor discharge itching irritation and dryness
VH-01 is a multi-strain vaginal synbiotic designed to seed and sustain an optimal and protective CST I vaginal ecology The product delivers an ecology of complimentary Lactobacillus crispatus and synbiotic ingredients to promote an optimal vaginal ecology The strains were selected to confer maximal vaginal microbiome stability in response to potential perturbations such as menstruation sex exercise medication and other environmental influences
The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a prebiotic and multiple strains of Lactobacillus crispatus associated with a stable vaginal microbiome
Lactobacillus crispatus produces lactic acid and other compounds that maintain an optimal vaginal pH which discourages the growth of harmful microbes that lead to disruptions in the vaginal microbial ecosystem These disruptions may increase vaginal discomforts such as vaginal malodor discharge itching irritation and dryness
VH-01 is a multi-strain vaginal synbiotic designed to seed and sustain an optimal and protective CST I vaginal ecology The product delivers an ecology of complimentary Lactobacillus crispatus and synbiotic ingredients to promote an optimal vaginal ecology The strains were selected to confer maximal vaginal microbiome stability in response to potential perturbations such as menstruation sex exercise medication and other environmental influences
The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a prebiotic and multiple strains of Lactobacillus crispatus associated with a stable vaginal microbiome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None