Who is conducting the study?
Validcare on behalf of Garden of Life and their Once Daily Women’s Probiotic product.
What kind of product will I be using?
Study participants will be randomly assigned to either the active product (Dr. Formulated Once Daily Women’s Probiotic*) or placebo group. All products will be consumed via an oral capsule.
*Dr. Perlmutter created this unique “just one capsule a day”, shelf-stable probiotic designed to support a woman’s microbiome with a high count of diverse probiotic strains including L. reuteri and L. fermentum to support women’s digestive, immune system and vaginal health. With a high CFU count and specially selected probiotic strains, Once Daily Women’s also contains an organic whole food prebiotic fiber blend for optimal benefit.
What will happen to my vaginal pH measurement results?
All data and records generated during this study will be kept confidential in accordance with HIPAA privacy and the Investigator and other personnel will not use such data and records for any purpose other than conducting the study. Your results will be blinded and made available to the Principal Investigator conducting the study via a HIPAA compliant secure portal. Your name will not be associated with your final results in the study submission and write up. Your results will be combined with those of the 200+ other participants, and eventually included in FDA studies as well as published in peer-reviewed national medical journals.
What exactly are you looking for in the pH measurement?
Scientists will be looking to to compare the change in vaginal pH in both normal women and in normal women with a history of BV to and after treatment with Once Daily Women’s Probiotic vs. placebo.
What if I am unable or unwilling to complete the study?
You may voluntarily terminate participation at any time during the study. The Principal Investigator may terminate your involvement as well after enrollment based on any reasonable criteria (including but not limited to the Investigator’s concern for your safety, truthfulness, etc).
What are the risks of taking a probiotic?
Probiotics are generally safe, and any side effects are usually mild and short-lived. However, if a symptom is causing concern, consider reducing the probiotic’s dosage, trying a different strain, or stopping use altogether.
How will I know that I have successfully completed the study and earned the $200?
You will have successfully completed the study if you have journaled your use of oral You will have successfully completed the study if you have journaled your use of oral Study Product for a minimum of 20 days per cycle/month (4 cycles/months total) AND provided a self-reported vaginal pH measurement AND answered required queries for 3 or more times each cycle/month.
What will I do as part of the study?
- You will complete 3 surveys to complete enrollment in the study and to provide your shipping address for study materials and product.
- During a preparation phase, you will conduct 5 test measurements of vaginal pH using a provided sterile swab and pH measurement strip.
- During a baseline phase, (~30 days), you will measure your vaginal pH and fill out some questionnaires once a week for 1 month (~10-15 minutes total per week).
- During the product testing phase (~ 90 days), answer daily surveys confirming product use (~1 minute per day) and measure your vaginal pH and fill out some questionnaires once a week for about 3 months (~10-15 minutes total per week).