A total of 40 patients
, although you might be more familiar with its grown up name, . of women do not naturally produce these critical strains of lactobacilli.
van de Wijgert, J., & Jespers, V. (2017). The aim of this study is to determine if Flourish Vaginal Care System aids in re-establishing
This is a booklet containing detailed instructions for
United States. 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. obtained from interview will be analyzed. also complete the vulvovaginal symptoms questionnaire (VSQ). Restore, a 510K-cleared moisturizing personal lubricant that has been on the market for 3
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. Ideal for women who experience vaginal dryness due to: hormone fluctuations including birth control pills, post childbirth and menopause,medications that cause mucus membranes to dry including antihistamines, antidepressants, opioids / pelvic pain or pain with sex. 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. These visits and all other study related visits
Homeopathy rests on the principle that like treats like and less is more. The theory is that the active ingredient in any homeopathic treatment is diluted so much that the few molecules remaining (that is if any remain) are more potent than the original. Nasioudis, D., Linhares, I. M., Ledger, W. J., & Witkin, S. S. (2017). https://www.fda.gov/drugs/information-drug-class/homeopathic-products. It will also assess the ability of subjects to comply with
: This is not technically an intervention. * It is postulated that lubricants and moisturizers may predispose to BV by altering the pH of the vagina. BV is also associated with serious pelvic infections as well as complications after abortion and hysterectomy, and with premature delivery. Bacteriocins and other bioactive substances of probiotic lactobacilli as biological weapons against Neisseria gonorrhoeae. Restore has a pH of 3.7 with
will be with either the PI or sub-investigator. 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. Good Clean Love is recommended by health professionals nationwide and was declared "among the safest products on the market"_ by research conducted at Johns Hopkins University. BV has also been associated with an increased risk of preterm labor, STD acquisition, and vaginal cuff cellulitis after hysterectomy6. In a surprising twist, probiotics are listed on the website as an inactive ingredient.
Its important to point out that this study in the NEJM I just referenced in no way supports the use of Bio.pHresh.
Inactive ingredients typically means inert ingredients the stuff brought along for the ride so the active ingredients stay active and are dispersed in a way that they reach their target tissues. Bacterial vaginosis: a critical analysis of current knowledge. a packet of study materials from a study physician/clinician or the research nurse as well as
At Fullscript, we are committed to curating accurate, and reliable educational content for practitioners and patients alike. I am not sure if listing probiotics as an inactive ingredient was a way to skirt FDA regulations or perhaps they dont know what an inactive ingredient means? will be enrolled; 20 in a shorter (12-week) preliminary study without microbiome analysis,
That is the allure of homeopathy. found in most bar soaps and OTC cleansers, which tend to disrupt the cell to cell adhesion
This section also evaluates the ability of a company to protect their mission and formally consider stakeholders in decision making through their corporate structure (e.g. Once enrolled, each subject will be assigned a study number by the research nurse and receive
If the item details above arent accurate or complete, we want to know about it. BIOPHRESH HOMEOPATHIC VAGINAL SUPPOSITORYActive Ingredients Per Dose (purpose):Kreosotum 6C HPUS; Nitricum Acidum 6C HPUS(vaginal itching and irritation); Thuja Occidentalis 6C HPUS*; Pulsatilla Vulgaris 6C HPUS* (vaginal odor); Sepia Officinalis 6C HPUS* (vaginal discharge). All medical statements are linked to the original reference and all sources of information are disclosed within the article. The study may be prematurely terminated if it is determined that an abnormal number of
Test. In addition, the concept that like treats like means that, for example. Edwards D, Panay N. Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition? range and keep the growth of BV associated bacteria at low levels. Ruz FO, Pascual L, Giordano W, Barberis L. Bacteriocins and other bioactive substances of probiotic lactobacilli as biological weapons against Neisseria gonorrhoeae. This study is designed to be a pilot/feasibility study. Data from the participants' diaries and data
So not a knock out of the park, but perhaps a piece of the puzzle. Currently, there are many sexual lubricants and vaginal moisturizers available on the market. Women with bacterial vaginosis received standard antibiotic therapy and then were randomized to the vaginal probiotic lactobacillus crispatus or placebo. See how we make shopping for wellness even easier. If you have specific healthcare concerns or questions about the products displayed, please contact your licensed healthcare professional for advice or answers. third aim is to determine what the vaginal microbiome community state type is after 6 months
The secondary aim is to determine
if the continued use of Flourish will prevent recurrence of BV over a 6 month period. 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. Women who think they have BV should see a health care provider so they can get the right diagnosis (BV has identical symptoms to the sexually transmitted infection trichomonas) and treatment. If you have been using homeopathic remedies because you thought they were natural, and never really read into the details of what those little pills under your tongue are all about, you are not alone. screened as per the providers' discretion for GC/ CH and trichomonas if it seems indicated
This is due to the belief that the memory of the original substance remains. and a difficult one to treat. times for the duration of the study. Information about supplements is always based on ingredients. Multiproduct system for vaginal care and relief from symptoms associated with bacterial vaginosis. Actual Study Start Date
And I would never recommend trusting your health to a company or a provider that believes in homeopathy. Women with bacterial vaginosis received standard antibiotic therapy and then were randomized to the vaginal probiotic lactobacillus crispatus or placebo. Your continuous help and shared info I just love! *These statements have not been evaluated by the Food and Drug Administration. A secondary aim is to determine how well study subjects are able to adhere to the study protocol. It has recently been shown that many of these are hyperosmolar and it is thought that
This system is comprised of a vaginal wash (Balance), an intravaginal moisturizing gel (Restore), and a vaginal probiotic supplement (BiopHresh). doi: 10.1093/femspd/ftv013. While BV responds well to antibiotic therapy, there is a high recurrence rate up to one-third of women with BV can have a recurrence in 3 months and by 12 months that number rises to about 50%. triggering by sensitive questions or procedures. participants' diaries and results of swab tests will be collected from participating
Treatment of bacterial vaginosis. BALANCE MOISTURIZING WASHAloe Barbadensis Leaf Juice, Cocamidopropyl Hydroxysultaine, Sodium Cocoamphoacetate, Glycerin, Lauryl Glucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucoside Carboxylate, Dimethyl Lauramide / Myristamide, Natural Lavender Flavor, Lactic Acid, Coco-Glucoside, Glyceryl Oleate, Mahonia Aquifolium Root Extract, Hydrastis Canadensis (Goldenseal) Extract, Allium Sativum (Garlic) Bulb Extract, Calendula Officinalis Flower Extract, Potassium Sorbate, Sodium Benzoate. In three easy steps, the Flourish regimen promotes good hygiene, helps restore healthy pH-levels, and delivers beneficial bacteria, including Lactobacillus Crispatus, to help reduce recurrence of symptoms. Normal vaginal flora is lactobacilli dominant. The study confirmed the diagnosis of BV, there was active treatment with antibiotics, and there was only one ingredient, the. When vaginal area is clean and dry insert the capsule using the provided applicator. The last. It is characterized by a shift in vaginal flora from an acidic environment due to acid-producing lactobacilli to a mixture of anaerobic and facultative microorganisms. 0 subscriptions will be displayed on your profile (edit). administered vaginally (one of the ingredients in Good Clean Love). For your security, we need to re-authenticate you. 2007 Jan;109(1):114-20. Anything that alters the vaginal flora and changes the pH to a more basic environment may increase the risk of BV. Obstetrics and gynecology, 109(1), 114120. Medically-speaking, the way a person should relieve symptoms of bacterial vaginosis is not with an untested over-the-counter product, but rather they should see a medical provider to get a correct diagnosis and a prescription of antibiotics. The Flourish kit combines three Good Clean Love gynecologist-recommended care products, providing 30 days of improved wellness while reducing the itch, irritation, and odour that can be associated with BV. Then think again. 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.
You cant compare a tested product with a single ingredient with an untested product with multiple other ingredients. The idea that probiotics, meaning live beneficial bacteria like those found in the vagina (such as lactobacillus crispatus, lactobacillus rhamnosus, and lactobacillus reuteri, etc), could be used to help with BV is an active area of research. For subjects in the shorter study, subjects will be screened for BV/yeast, vaginal Low quality studies aside, the other reason that we have not made a lot of traction with probiotics and BV is the vaginal microbiome is very complex. The Affirm test, wet mount, and vaginal pH will Homeopathy not only doesnt make scientific sense, it doesnt even make common sense. If irritation occurs, discontinue use and seek medical advice. *HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States. On the first day of enrollment, subjects will be screened for BV using the Affirm VPIII test, What is this? choosing a selection results in a full page refresh. 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. Sold in over 20,000 retail locations, Good Clean Love is proud to be the top-selling organic intimacy brand on the U.S. market. Resources for patients are intended to be educational and do not replace the relationship between health practitioners and patients. Flourish Vaginal Care System offers an advanced daily regimen for the vaginal biome plus added relief from symptoms of bacterial vaginosis (BV). Demographic and past medical history information will also be collected at this visit. The active ingredient in Good Clean Loves Bio.pHresh Vaginal Homeopathic Suppositories are. All rights reserved. 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. The Flourish regimen uses patented Bio-Match technology to cleanse, moisturize and restore pH-balance; promoting healthy vaginal conditions. Better vaginal health is now available in three easy steps. quality of life, sexual relations, self-image and well-being. [6 months], Study Director: Wendy Strgar, Sexual Health & Wellness Institute, Concord, Obstet Gynecol. This will which provides a clinically-tested combination of lactobacilli including L. crispatus and No specific products are mentioned or promoted within educational content. After the initial visit, every third day until the completion of the study. 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. After treatment with antibiotics, recurrences are common. racemic 1% lactic acid, and is iso-osmolar with serum.
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