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De Simone Formulation
The De Simone Formulation is a probiotic formula and manufacturing method developed by Claudio De Simone. The De Simone Formulation has been clinically studied for a variety of health conditions since the 1990s but it has been researched the most for its efficacy in the medical management of chronic intestinal conditions including irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD). Lawsuits The De Simone Formulation has been the subject of lawsuits. In the United States, the 4th U.S. Circuit Court of Appeals upheld a false advertising verdict against the makers of the VSL#3 probiotic in February 2021 stating there was enough evidence to support a jury's November 2018 finding that the makers of VSL#3 had quote "reverse-engineered an imperfect copy" of De Simone's signature probiotic formulation that was sold under the brand name VSL#3 through May 2016 after he withdrew from their joint venture, VSL Pharmaceuticals Inc. According to the lawsuit, his departure wa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Probiotic
Probiotics are live microorganisms that provide health benefits when consumed, generally by improving or restoring the microbiota in the gut. Probiotics are considered generally safe to consume, but may cause bacteria– host interactions and unwanted side effects in rare cases. There is some evidence that probiotics are beneficial for some conditions, such as helping to ease some symptoms of irritable bowel syndrome (IBS). However, many claimed health benefits, such as treating eczema, or curing vaginal infections lack substantial scientific support. The first discovered probiotic was a certain strain of bacillus in Bulgarian yoghurt, called '' Lactobacillus bulgaricus''. The discovery was made in 1905 by Bulgarian physician and microbiologist Stamen Grigorov. The modern-day theory is generally attributed to Russian Nobel Prize laureate Élie Metchnikoff, who postulated around 1907 that yoghurt-consuming Bulgarian peasants lived longer. A growing probiotics market has ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by a group of symptoms that commonly include abdominal pain, abdominal bloating, and changes in the consistency of bowel movements. These symptoms may occur over a long time, sometimes for years. IBS can negatively affect quality of life and may result in missed school or work or reduced productivity at work. Disorders such as anxiety, major depression, and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are common among people with IBS.The cited review is based on sources ranging from 1988 to 2001 and is probably biased relative to a more recent research. The cause of IBS is not known but multiple factors have been proposed to lead to the condition. Theories include combinations of " gut–brain axis" problems, alterations in gut motility, visceral hypersensitivity, infections including small intestinal bacterial overgrowth, neurotransmitters, genetic factors, and food ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the colon and small intestine, with Crohn's disease and ulcerative colitis (UC) being the principal types. Crohn's disease affects the small intestine and large intestine, as well as the mouth, esophagus, stomach and the anus, whereas UC primarily affects the colon and the rectum. Signs and symptoms In spite of Crohn's and UC being very different diseases, both may present with any of the following symptoms: abdominal pain, diarrhea, rectal bleeding, severe internal cramps/muscle spasms in the region of the pelvis and weight loss. Anemia is the most prevalent extraintestinal complication of inflammatory bowel disease (IBD). Associated complaints or diseases include arthritis, pyoderma gangrenosum, primary sclerosing cholangitis, and non-thyroidal illness syndrome (NTIS). Associations with deep vein thrombosis (DVT) and bronchiolitis obliterans organizing pneumonia (BOOP) have also been reported. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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False Advertising
False advertising is the act of publishing, transmitting, distributing or otherwise publicly circulating an advertisement containing a false claim, or statement, made intentionally, or recklessly, to promote the sale of property, goods or services. A false advertisement can be classified as deceptive if the advertiser deliberately misleads the consumer, rather than making an unintentional mistake. A number of governments use regulations or other laws and methods to limit false advertising. Types of deception False advertising can take one of two broad forms: an advertisement may be factually wrong, or intentionally misleading. Both types of false advertising may be presented in a number of ways. Photo manipulation Photo manipulation is a technique often used in the cosmetics field and for weight loss commercials to advertise false (or non-typical) results and give consumers a false impression of a product's capabilities. Photo manipulation can alter the audience's percep ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Injunction
An injunction is an equitable remedy in the form of a special court order compelling a party to do or refrain from doing certain acts. It was developed by the English courts of equity but its origins go back to Roman law and the equitable remedy of the "interdict". "When a court employs the extraordinary remedy of injunction, it directs the conduct of a party, and does so with the backing of its full coercive powers."'' Nken v. Holder''556 U.S. 418, 428 (2009) (citation and internal quotation marks omitted). A party that fails to comply with an injunction faces criminal or civil penalties, including possible monetary sanctions and even imprisonment. They can also be charged with contempt of court. Rationale The injunction is an equitable remedy that was created by the English courts of equity. Like other equitable remedies, it has traditionally been given when a wrong cannot be effectively remedied by an award of money damages. (The doctrine that reflects this is the req ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Clinical Studies
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Probiotics
Probiotics are live microorganisms that provide health benefits when consumed, generally by improving or restoring the microbiota in the Gut microbiota, gut. Probiotics are considered GRAS, generally safe to consume, but may cause bacteria–Host (biology), host interactions and unwanted side effects in rare cases. There is some evidence that probiotics are beneficial for some conditions, such as helping to ease some symptoms of irritable bowel syndrome (IBS). However, many claimed health benefits, such as treating eczema, or curing vaginal infections lack substantial scientific support. The first discovered probiotic was a certain strain of bacillus in Bulgarian yoghurt, called ''Lactobacillus bulgaricus''. The discovery was made in 1905 by Bulgarian physician and microbiologist Stamen Grigorov. The modern-day theory is generally attributed to Russian Nobel Prize laureate Élie Metchnikoff, who postulated around 1907 that yoghurt-consuming Bulgarian peasants lived longer. A ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Medical Food
Medical food is food that is specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States, it was defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe, the European Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015. Definition Medical foods, called "food for special medical purposes" in Europe, are distinct from the broader category of foods for special dietary use, from traditional foods that bear a health claim, and from dietary supplements. In order to be considered a medical food the product must, at a minimum: * be a food for oral ingestion or tube feeding ( nasogastric tube) * be labeled for the dietary management of a specific medical disorder, disease or condition fo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Therapy
A therapy or medical treatment is the attempted remediation of a health problem, usually following a medical diagnosis. Both words, ''treatment'' and ''therapy'', are often abbreviated tx, Tx, or Tx. As a rule, each therapy has indications and contraindications. There are many different types of therapy. Not all therapies are effective. Many therapies can produce unwanted adverse effects. ''Treatment'' and ''therapy'' are often synonymous, especially in the usage of health professionals. However, in the context of mental health, the term ''therapy'' may refer specifically to psychotherapy. Semantic field The words ''care'', ''therapy'', ''treatment'', and ''intervention'' overlap in a semantic field, and thus they can be synonymous depending on context. Moving rightward through that order, the connotative level of holism decreases and the level of specificity (to concrete instances) increases. Thus, in health-care contexts (where its senses are always nonc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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Gastroenterology
Gastroenterology (from the Greek gastḗr- "belly", -énteron "intestine", and -logía "study of") is the branch of medicine focused on the digestive system and its disorders. The digestive system consists of the gastrointestinal tract, sometimes referred to as the ''GI tract,'' which includes the esophagus, stomach, small intestine and large intestine as well as the accessory organs of digestion which include the pancreas, gallbladder, and liver. The digestive system functions to move material through the GI tract via peristalsis, break down that material via digestion, absorb nutrients for use throughout the body, and remove waste from the body via defecation. Physicians who specialize in the medical specialty of gastroenterology are called gastroenterologists or sometimes ''GI doctors''. Some of the most common conditions managed by gastroenterologists include gastroesophageal reflux disease, gastrointestinal bleeding, irritable bowel syndrome, inflammatory bowel disease (IBD ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |