The secondary aim is to determine if the continued use of Flourish will prevent recurrence of BV over a 6 month period. But probiotics are an active ingredient, that is why we are studying them to see if they can be helpful in preventing BV.
Restore, a 510K-cleared moisturizing personal lubricant that has been on the market for 3
Then there is the issue that a significant percentage of probiotics dont contain the bacteria colonies that they claim. Pioneering in the sexual health industry with organic solutions, Good Clean Love is responsible for innovations such as Bio-Match technology and the first water-based lubricant with organic hemp oil, CBD CaraGold Premium Personal Lubricant. vaginal 2oz moisturize restore gel balance applications ph clean Climacteric. These ingredients are listed as a 6C dilution, that is one partin one trillion if I did the math right, meaning the ingredientsare so diluted as to be undetectable. Test. of women do not naturally produce these critical strains of lactobacilli. Each kit includes a one-month supply of Balance Personal Wash (1 oz.
I no longer recommend them given the low quality of available data, the lack of improvement that Ive seen with these products, and the cost some of them are $30-60 a month. Womens personal care company Good Clean Love is adding to its slate of products with two OTC options meant to help treat bacterial vaginosis symptoms. each day of the study as well as a diary in which participants will record daily symptoms. A secondary aim is to determine how well study subjects are able to adhere to the study protocol. It is, therefore, much less likely to alter the acid-base balance of the vagina, and therefore less likely to predispose to bacterial vaginosis. $16.00, Regular price Sign up to our Insights newsletter, a monthly digest of the latest news on economic systems change from B Lab Global. Flourish Vaginal Care System offers an advanced daily regimen for the vaginal biome plus added relief from symptoms of bacterial vaginosis (BV). Anything that
There is no proof that Good Clean Loves Bio.pHresh Vaginal Homeopathic Suppositories can help, and frankly, anything that is homeopathic is based on a scam. The study may be prematurely terminated if it is determined that an abnormal number of
choosing a selection results in a full page refresh. months, the subject will be rescreened for BV using the Affirm VPIII test, vaginal pH and
of these visits they will be treated using standard of care and continue using the system as
Potential conflicts of interest are clearly disclosed. 2017 Nov - Dec;168(9-10):859-864. doi: 10.1016/j.resmic.2017.02.003. Might one community state respond better to probiotics than others? vaginal odor, itching, discharge and irritation and can greatly impact a woman's health,
The global health impact of vaginal dysbiosis. benefits, she will sign the informed consent and be enrolled in the trial.
Good Clean Love should not be given the benefit of the doubt that this suppository is safe for the vagina. BV causes symptoms of
years.
the only Sponsor staff that will have access to patient information including patient names
Finally, many so-called natural products are adulterated, so you are taking the word of a company that believes in homeopathy that their product contains what it claims and nothing else. The median score for ordinary businesses who complete the assessment is currently 50.9. The underlying issue with BV appears to be a problem with the vaginal microbiome, meaning the vaginal bacteria are not reducing the pH sufficiently and/or producing enough of the substances that keep harmful bacteria in check. No specific products are mentioned or promoted within educational content. Remember, Like treats like..
It is available without a prescription. gel lubricant , although you might be more familiar with its grown up name, . will be enrolled; 20 in a shorter (12-week) preliminary study without microbiome analysis,
vaginal or BV is a common cause of vaginal discharge, irritation and odor and is associated with a disturbance in the vaginal microbiome. All rights reserved. every third day until the completion of the study. Copyright 2022 B Lab. Larsson P. G. (1992). BV has also been associated
Its very toxic if inhaled and is also quite corrosive. In addition, the concept that like treats like means that, for example. Its important to point out that this study in the NEJM I just referenced in no way supports the use of Bio.pHresh. Might someone use this product and delay appropriate therapy as they mistakenly believed it could treat BV? Bacterial vaginosis is the most common and least treated of all genital infections, impacting between 30% to 50% of reproductive-aged women; [it] has even higher rates of recurrence in African-American women., Typical treatment for the condition is a round of antibiotics by prescription, which can have the effect of killing both the good and bad bacteria and disrupting the vaginal biome, the company said. Combination Product: Flourish Vaginal Care System, BV recurrence (assessed using Affirm VPIII test, BD Diagnostics) [6 months], Vaginal microbiome (assessed using the Juno Vaginal Microbiome Test, a next-generation sequencing technology) [6 months], Yeast infections (assessed using the Affirm VPIII test) [6 months], Protocol compliance via qualitative analysis of daily journal entries. After treatment with antibiotics, recurrences are common. The Affirm test, wet mount, and vaginal pH will
It is
Allsworth JE, Peipert JF. sub-investigator, with a history of at least one prior episode of BV in the past year,
Data from the participants' diaries and data
Transforming the global economy to benefit all people, communities, and the planet. A company with an Impact Business Model is intentionally designed to create a specific positive outcome for one of its stakeholders - such as workers, community, environment, or customers. restore Lactobacilli also produce proteins with the bactericidal activity which help to maintain their dominance. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. When all participants have completed the study with the participating clinicians,
a packet of study materials from a study physician/clinician or the research nurse as well as
Restore will be used every other day. Sponsor of the study, will not interact directly with participants but will have a staff
RESTORE MOISTURIZING VAGINAL GELOrganic Aloe Barbadensis Leaf Juice, Xanthan Gum, Lactic Acid, Natural Flavor, Potassium Sorbate, and Sodium Benzoate. If the subject chooses to participate after a thorough discussion of the risks and
No study has shown homeopathy works for any condition and the principle of dilution is not consistent with the laws of chemistry and physics. In order to provide unbiased and transparent education, information is based on a research review and obtained from trustworthy sources, such as peer-reviewed articles and government websites. Then think again. Nasioudis D, Linhares IM, Ledger WJ, Witkin SS. levels, the presence of specific strains of lactobacilli. The results do not provide sufficient evidence for or against recommending probiotics for the treatment of BV. Most studies published since then have not produced any dramatic or meaningful results, largely due to the lower quality of the studies. A total of 40 patients
Resources for patients are intended to be educational and do not replace the relationship between health practitioners and patients. Good Clean Love Bio-Match Restore pH Balanced Moisturizing Gel is formulated under the guidance of independent scientific research and mimics the body's natural lubricating response, accurately Bio-Matching pH, salt balance, and lactobacilli of the healthiest vaginal conditions. Patented scientific advanced formula - clinical study pending for the natural treatment and prevention of odor caused by bacterial vaginosis (BV), 95% Organic, paraben free, petrochemical free, glycerin free, 100% Isotonic, water-based and condom compatible, pH balanced to ideal vaginal conditions, matches women's natural lubrication. It has recently been shown that many of these are hyperosmolar and it is thought that
BiopHresh Vaginal Probiotic Suppository, a Bio Matched probiotic homeopathic formulation
Larsson PG. The company is launching the BiopHresh Vaginal Homeopathic Suppository and the Flourish Vaginal Care System, which Good Clean Love said are the first products of their kind., For years, I've been working to develop products that help maintain a healthy vaginal biome and prevent the discomfort that comes from recurrent Bacterial Vaginosis, which so many women experience," said Wendy Strgar, founder and CEO of Good Clean Love. Actual Study Start Date
BV has also been associated with an increased risk of preterm labor, STD acquisition, and vaginal cuff cellulitis after hysterectomy. BV symptoms include vaginal odor, itching, discharge, and irritation and can greatly impact a womans health, quality of life, sexual relations, self-image, and well-being. 2007 Jan;109(1):114-20.Allsworth, J. E., & Peipert, J. F. (2007).
clinicians, and clinical experiences during the trial will be obtained by short in person
which provides a clinically-tested combination of lactobacilli including L. crispatus and
Epub 2015 Dec 26. Review. It will also assess the ability of subjects to comply with
quality of life, sexual relations, self-image and well-being. I wont try it for recurrent BV. In the United States, the National Health and Nutrition Examination Survey (NHANES), estimated the prevalence of BV was 29% in the general population of women aged 14 to 49 years and 50% in African-American women. Lactobacilli maintain vaginal pH in the acidic range and keep the growth of BV associated bacteria at low levels. 0 subscriptions will be displayed on your profile (edit). It is made without toxic saponifiers found in most bar soaps and OTC cleansers. The homeopathic ingredients in Good Clean Loves Bio.pHresh include the following: Kreosotum, according to HomeopathyPlus! The Workers Impact Area evaluates a company's contributions to its employees' financial security, health and safety, wellness, career development, as well as overall engagement and satisfaction. extracts, formulated with more than 60% premium aloe. Examination Survey (NHANES), estimated the prevalence of BV was 29 percent in the general
But hey, Im willing to learn. alter the acid base balance of the vagina, and therefore less likely to predispose to BV. Make sure the applicator is clean and dry before reusing. All content is updated on a regular basis to account for new research and industry trends, and the last update date is listed at the top of every article. same procedures and also have a vaginal swab done for analysis by the Juno Vaginal Microbiome
Research has shown as many as 30%
Add that with the money to be made in vaginal shame, plus the fact that recurrent BV is a complex condition and many women are desperate for solutions, and youve got a gold mine.
Some examples might include products and services that create renewable energy, reduce consumption or waste, conserve land or wildlife, provide less toxic alternatives to the market, or educate people about environmental problems.
The first aim of this study is to determine if Flourish Vaginal Care System is able to reduce the vaginal pH to a health level (pH 3.5-4.2) in order to support a healthier vaginal microbiome. *, Wash hands before use. On their website Good Clean Love claims their Bio.pHresh Vaginal Homeopathic Suppositories help relieve symptoms related to bacterial vaginosis, including itching, irritation, vaginal odor, or abnormal discharge and promotes urinary tract health. They also claim it will help maintain a healthy vaginal pH.. There are no clinical trials of this product, meaning there is zero data to support these assertions. Homeopathy not only doesnt make scientific sense, it doesnt even make common sense. This study is designed to be a pilot/feasibility study. Rinse well. Supplemental information provided by Good Clean Love: The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans.
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