Yes. PS128^TM is a proprietary strain only sold by Bened Life^® in the US, and by Bened Life authorized health care providers. Any other brand advertising these strains for sale in the US is selling counterfeit products. Make sure to look for the Neuralli^® brand and Bened Life^® to ensure you are purchasing real PS128^TM.

Neuralli^® MP comes in capsules packaged in a twist-off bottle. These state-of-the-art CSP vials keep the inside of the bottle very dry and help maintain maximum probiotic potency.

If swallowing the capsule is uncomfortable, you can open the shell and take the powder. (Take it all at once to guarantee its potency.) If you’d like, you can mix Neuralli^® MP powder into a cool drink or food of your choice. It should not be added to warm/hot foods or liquids. Read more here

The FDA approves drugs (or medicines). Neuralli^® MP is not a drug or medicine. It is a probiotic medical food.

A medical food is defined by 21 U.S. Code 360ee, (b), (3) as a food formulated for consumption or enteral administration under the supervision of a physician for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

Neuralli^® MP is a medical food intended for the dietary management of autism and Parkinson’s disease. Lactiplantibacillus (formerly Lactobacillus) plantarum PS128^TM is the probiotic strain that, at sufficiently high quantities, when administered to people with the specified neurological conditions, has demonstrated some benefits that are clinically meaningful.

L. plantarum PS128^TM is self-affirmed as generally recognized as safe (GRAS). The strain L. plantarum PS128^TM is derived from a fermented food. The fermented food itself is not in a typical diet and does not have the standardized quantities of the specific strain, PS128^TM. To maintain the strain's genetic integrity, it must be cultivated in controlled manufacturing conditions. To deliver a sufficient quantity to have a clinically meaningful effect, Neuralli^® MP delivers PS128^TM in a high-potency form.

When taking Neuralli^® MP as directed (2 capsules containing 60 billion CFU of L. plantarum PS128^TM), some people may experience mild gastrointestinal upset such as gas, bloating or stool changes for up to a week, just as when starting any new probiotic. In clinical studies of the PS128^TM probiotic with Autistic participants or patients with Parkinson’s disease, reports of adverse effects were very low. If side effects persist, we recommend consulting your health care provider.

Children as young as 3 years of age have used 60 billion CFUs of PS128^TM per day in clinical studies. These children were under the supervision of physicians for their diagnosis of autism. Two capsules of Neuralli^® MP contain 60 billion CFUs of PS128^TM.

Neuralli^® MP is a medical food for the dietary management of autism, and is intended to be used under the supervision of a health care professional.

Neuralli^® MP delivers 60 billion CFUs of L. plantarum PS128^TM to contribute to healthy gut microbiota. As a medical food for autism or PD, Neuralli^® MP targets gut microbiome-to-brain signaling.

More research is needed to explore the impact of PS128^TM on bowel function such as constipation. However, in a recent customer survey of 132 respondents taking Neuralli^® MP, about half experienced some improvements or significant improvements in their gut health. Less than half experienced no change to gut health.

No probiotic can replace the need for adequate intake of fiber (about 25-35 grams per day) or other healthy lifestyle habits that impact gut health. Consult your health care practitioner for concerns about your digestive health.

Neuralli^® MP is most effective when taken daily. The benefits of Neuralli^® MP come from its probiotic strain, and the strain itself doesn’t colonize in your gut. Therefore, if you don’t take it, you will not be getting the good bacteria. That said, if you miss a day, there’s no need to take a double dose to make up for it. Simply start again the next day.

It is unknown if PS128^TM can reproduce within the human intestine. Unpublished research shows that PS128^TM DNA could be detected in the stool of some volunteers for 1-2 weeks after taking the strain. However, it is not known if PS128^TM was alive and reproducing within the intestine over that period.

Probiotics typically provide benefits as they are taken and pass through the intestine. It is not necessary for them to “colonize” the gut in order to be effective. It is rare for any probiotic strain to be retained in the gut once a person stops taking it.

You can read more about probiotic colonization in this article from the International Scientific Association for Probiotics and Prebiotics (ISAPP):
https://isappscience.org/is-probiotic-colonization-essential/

Because Neuralli^® MP is not shelf stable, we formulate, package, and ship it carefully. We don’t compromise in our pursuit of providing maximum potency for maximum benefit. We add in more than 30 billion CFUs of PS128^TM at the time of manufacturing to ensure you get at least 30 billion CFUs per capsule through the best by date. We use special CSP vials to keep the capsules dry. We ship fast and cold when it's very hot outside to prevent CFU loss, and use robust curbside recyclable insulated packaging to minimize our impact on the environment.

At Bened Life, we believe that safe and effective microbiome solutions are part of the answer. Your investment in Neuralli^® MP supports our mission to unlock the gut-brain axis and make an impact on the communities we serve.

Each serving (2 capsules) of Neuralli^® MP contains at least 60 billion CFU L. plantarum PS128^TM. Other ingredients include microcrystalline cellulose, magnesium stearate, and silica. The vegetarian capsule is made of hypromellose.

Prior to April 2024, Neuralli^® MP was marketed as Neuralli^®, and was formulated with <200 mg of inulin in addition to 60B CFU of PS128^TM per 2-capsule serving.

Inulin was removed for two reasons: To make the product accessible to people who are sensitive to inulin, and to make the formulation more similar to the one that was used in all clinical studies.

PS128^TM alone (without inulin) has been shown to provide benefits for Autistic people, as well as people with Parkinson’s disease. The lowest quantity of inulin that has been clinically shown to provide a benefit for increases in beneficial gut microbes is 2.5 g, which does not fit into a small capsule.

To keep your products maximally effective, store them in their original CSP bottles in the refrigerator. Be sure to keep Neuralli^® MP in its original bottle to limit the exposure of the capsules to humidity; do not store the capsules in a different container. Do not expose Neuralli^® MP to high heat or direct sunlight.

If you travel with Neuralli^® MP, always keep it in a cool, dry place. Storing a bottle at a consistent room temperature for up to one month will not impact the efficacy of the product.

Take two capsules every day. Many customers take both at the same time; however, you can also split them up if you prefer. Find the time of day that works best for you.

In a clinical study with people with Parkinson’s disease, participants took two capsules in the evening. In other clinical studies the timing was left up to the participants.

The serving size of Neuralli^® MP is 2 capsules per day, providing 60 billion CFU of PS128^TM. Children as young as 3 years of age have used 60 billion CFUs per day of PS128^TM in clinical studies.

Since each person is different, your tolerance may vary. Please take Neuralli^® MP under the supervision of your health care provider.

Most people take 1-2 capsules per day. Clinical studies have tested up to 60 billion CFU of PS128^TM, which is the quantity in 2 capsules. Consult your healthcare provider if you have any questions.

You may receive your product in a box with or without cold packs, depending on the time of year and your geographic location. If your package contains cold packs that are no longer cold, or perhaps even warm, when the box arrives at your door, don’t worry - your product is safe. Simply refrigerate all bottles right away.

Bened Life^® products are stable under most shipping conditions, but should be refrigerated upon receipt. PS128^TM requires refrigeration to retain efficacy through its best-by date.

If you happen to experience an unexpected heat wave or unusual circumstances such as product sitting at your door in excessive heat for an extended period of time, please contact our customer happiness team through our contact form.

As a medical food, Neuralli^® MP should be used under the supervision of your health care provider. Its active ingredient, PS128^TM, has been studied in Autistic people and people with Parkinson’s (see references here).

PS128^TM may play a role in modulating neurotransmitters such as dopamine and serotonin in some individuals. If you have concerns about this, please speak with your health care provider before starting or stopping Neuralli^® MP.

While each ingredient in Neuralli^® MP has been self-affirmed as Generally Recognized as Safe (GRAS), Neuralli^® MP has not been tested for safety and effectiveness in populations with other medical conditions. We recommend that you consult with your health care provider to decide if Neuralli^® MP is right for you.

If you are breastfeeding or pregnant, we recommend speaking to your health care provider for guidance. They will have the best recommendations for you with your health history in mind.

We always recommend consulting with your health care provider before starting any new medical food, supplement, or medication. Autistic participants, and those with PD, or Rett’s or Tourette’s syndrome continued their medications and therapies while taking PS128^TM in clinical trials. We do not have detailed information about which medications they took except for the levodopa in the PD trial. Please take Neuralli^® MP under the supervision of your health care provider.

Some antibiotics may make Neuralli^® MP less effective. If you are taking an antibiotic, please consult your health care professional for advice.

L. plantarum PS128^TM does not produce histamine. It does not have the histidine decarboxylase (hdc) gene in its genome.

Yes, the 60 billion CFU quantity of PS128^TM in Neuralli^® MP has been the focus of multiple research and clinical studies.

Preclinical studies suggest that the strain Lactiplantibacillus (formerly Lactobacillus) plantarum PS128^TM benefits the immune and digestive systems, as well as impacts mental health by reducing stress, reducing anxiety, and balancing dopamine and serotonin in the brain.

Clinical studies of PS128^TM in three randomized, placebo-controlled trials and one real-world study in autism demonstrate clinically meaningful outcomes suggesting a reduction in anxiety. A single arm study in Parkinson's suggested positive benefits of using L. plantarum PS128^TM as dietary management. Click here for more information about the science of PS128^TM. You can view the clinical studies about PS128^TM here.

While many strains of L. plantarum are commercially available as probiotics, the L. plantarum PS128^TM strain affected dopamine and serotonin in some parts of the brain in preclinical studies. PS128^TM also demonstrated benefits in clinical trials of people with neurological conditions.

In general, different strains of a single bacterial species can have very different beneficial effects. For example, L. plantarum Lpla33 demonstrated benefit in IBS-D. On the other hand, Lactobacillus plantarum LPLDL can help with cholesterol levels. (PS128^TM has not been studied for those effects, and neither of those strains have been studied in the way that PS128^TM has.)

PS128^TM is a specific strain of lactic acid bacteria that has been clinically shown to provide benefits, whereas lacto-fermented vegetables (vegetables that undergo fermentation by lactic acid bacteria) may contain any number of types of bacteria with unknown properties.

PS128^TM was discovered in spontaneously fermented mustard greens. “Spontaneous” fermentation occurs when bacteria in the environment (air, nearby surfaces) do the fermentation. To identify what type of bacteria is in a fermented product, isolation and genetic sequencing is needed. After screening hundreds of lactic acid bacteria, PS128^TM was selected from one spontaneous fermentation of mustard greens. Other fermented products would not be expected to have PS128^TM unless PS128^TM had been added into it.

In order to be called a fermented food on a commercial product, the food should contain at least 1 million CFU of live microbes per gram of food per US FDA requirements (see 21 CFR131.200). The live microbes may or may not be specified by species (plantarum or acidophilus for example) or strain (using letters and numbers). Thus, the fermented food may be a food with live cultures, not probiotics (see information from ISAPP).

On the other hand, a probiotic delivers a specific quantity of a specific bacterium that has a demonstrated health benefit. 60 billion CFU of PS128^TM per serving is the quantity that was used in clinical studies as dietary management of specific neurological conditions such as ASD and PD.

A specific type of probiotics, psychobiotics are defined as live microorganisms that when administered at adequate amounts, provide a mental health benefit. Neuralli^® MP contains the novel psychobiotic L. plantarum PS128^TM, clinically shown to provide both neurological and mental health benefits, likely due to its influence on the production and/or metabolism of serotonin and dopamine.

A probiotic medical food is a type of medical food. The term medical food, as defined in the Orphan Drug Act, is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."

Neuralli^® MP is a medical food intended to support the dietary management of autism and Parkinson's disease. It delivers 60B CFUs of Lactiplantibacillus (formerly Lactobacillus) plantarum PS128^TM, a probiotic strain that, at sufficiently high quantities, when administered to people with the specified neurological conditions, has demonstrated some benefits that are clinically meaningful.

Autistic people and those with Parkinson's disease have distinct nutritional requirements that differ from the general population. For these patients, diet alone is not sufficient to support gut microbiome to brain signaling. Gut microbial differences (or gut dysbiosis), as well as genetic and blood biomarkers, suggest that gut microbiome modulation of neurotransmitters and neurotransmitter metabolism may be dysregulated in these conditions.

Additionally, amino acid metabolism and serotonin and dopamine levels and/or metabolism are altered in the brain in both ASD and PD. Amino acids such as tryptophan and tyrosine are the respective precursors to serotonin and dopamine. Thus, gut dysbiosis, metabolic dysregulation and neurotransmitter differences in neurological conditions such as ASD and PD allow for the possibility to help regulation of all three via dietary management through nutrients including the microbe PS128^TM.

Neuralli^® MP’s formula contains PS128^TM for the dietary management of these conditions via its effects on gut microbiome-to-brain signaling. The specific strain L. plantarum PS128^TM is derived from a fermented food. The fermented food itself is not in a typical diet and does not have the standardized quantities of the specific strain. To maintain genetic integrity of the strain, it needs to be cultivated in controlled manufacturing conditions. Neuralli^® MP is formulated to deliver a sufficient quantity of PS128^TM to have a clinically meaningful effect.

Clinical studies of PS128^TM in autism and Parkinson's disease suggest that this specific strain supports the gut microbiome to brain signaling that influences brain and behavior. The evidence for autism includes three randomized, placebo-controlled clinical trials. For further information, please see the list of clinical trials here.

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