DS-01® comprises 24 scientifically-validated probiotic strains with a patented, non-fermenting prebiotic. This breakthrough formulation is paired with innovations in probiotic stabilization and a precision-release system to deliver strains to the lower small intestine to support systemic benefits, including digestive, heart, skin, and gut health.
Formulation
Digestive Health / Gut Immunity / Gut Barrier Integrity Probiotic Blend
On day four (or when you’re ready), increase to the full dose of 2 capsules at once, daily. Ideally, take both capsules on an empty stomach or at least 10 minutes prior to a meal.
Fig. 1 — Acclimation protocol
Fig. 1 — Acclimation protocol
Just as with any new diet, product, or change, you may experience a temporary acclimation period—some gastrointestinal discomfort, abdominal tightness, mild nausea, or changes in your stool. This can be very normal. In fact, an immediate physiological reaction is a sign that our probiotics are viable and attuning to your system. Any discomfort should subside within the first few weeks of consistent use.
If the discomfort does not subside, you may try experimenting with your DS-01® use. Try taking the capsules with food or one capsule in the morning and one in the evening.
Clinical Trials
DS-01® in Irritable Bowel Syndrome (IBS)
The objective of this placebo-controlled study is to assess the effect of the 24-strain Daily Synbiotic (SH-DS01) on the composition and metabolism of the intestinal microbiota as well as to evaluate a range of IBS symptoms in a cohort of 100 subjects with constipation—predominant (IBS-C) or mixed (IBS-M) irritable bowel syndrome. This study will be conducted under an Investigational New Drug application, as authorized by the US Food and Drug Administration. This is a requirement for testing dietary supplements among persons with chronic conditions or diseases.
Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder that is commonly seen in clinical practice. Specifically, it is a functional bowel disorder that is thought to result from a disorder of the gut–brain interaction. Though patients with IBS often have a heterogeneous symptom profile, the predominant theme is the presence of abdominal pain or discomfort that is usually relieved by defecation. Genetic background and environmental factors are important for the pathogenesis of IBS, but the precise cause of IBS is still unknown. The long-term goal of our study is to assess the functional impact of probiotics in subjects who suffer from gastrointestinal symptoms and have been diagnosed with IBS-C or IBS-M. Thus far, few studies have been conducted to objectively assess the impact of ingesting live microorganisms on the symptoms of IBS-C or IBS-M such as gas / bloating.
This protocol aims to assess the impact of a mix of 24-beneficial strains on individual gastrointestinal symptoms in a cohort of subjects with IBS-C or IBS-M. The design of this protocol is unique, as we are not only collecting urine, blood, and fecal tissue to assess mechanism of action, but we will also ask the subjects recruited to use a smartphone application to report day-to-day gastrointestinal symptoms such as bloating. This trial is being conducted at Harvard’s Beth Israel Deaconess Medical Center, and began recruitment in 2020.
Impact of DS-01® on Post-Antibiotic Recovery
The objective of this study is to assess the effect of SH-DS01 on the gut microbiota of healthy adults after taking a course of broad-spectrum antibiotics.
In the United States, healthcare providers prescribe over 270 million antibiotic courses each year. While antibiotics have transformed medicine and methods of treating life-threatening bacterial infection, broad spectrum antibiotics also induce disruption of resident gut microbial communities by altering both composition and function. This disruption of microbial community dynamics has been demonstrated at the taxonomic level, yet the extent of functional disruptions to microbial metabolic output and host cells remains understudied in humans. This study explores the impact of a broad spectrum antibiotic cocktail on microbial communities throughout the gastrointestinal tract, and the rescue effects of a defined, multi-strain consortia of probiotic organisms following antibiotic exposure. This trial began recruitment in Q3 2020.
Strain-Specific Benefit Studies
Benefit
Studies
Digestive Health
Del Piano et al. J Clin Gastroenterol. 2010 Ogata et al. Biosci Microflora. 1997 Laparra & Sanz. J Cell Biochem. 2010 Olivares et al. J Agric Food Chem. 2011
Gut Barrier Integrity
Iemoli et al. J Clin Gastroenterol. 2012 ‡ Magistrelli et al. Front Immunol.2019†† De Palma et al. J Leukoc Biol. 2012
Gut Immune Axis
Long Yan Fong et al. J Funct Foods. 2016 Rodes et al. J Micro Biotech. 2013 Olivares et al. J Agric Food Chem. 2011 Iemoli et al. J Clin Gastroenterol. 2012‡ Drago et al. Allergy Asthma Immunol Res. 2015 Magistrelli et al. Front Immunol. 2019†† Mogna et al. J Clin Gastroenterol. 2012
Cardiovascular Health
Costabile et al. PLoS One. 2017 Bordoni et al. Appl Microbiol Biotechnol. 2013 Keleszade et al. J Func Foods. 2022
Dermatological Health
Iemoli et al. J Clin Gastroenterol. 2012‡ Climent et al. Microorganisms. 2021††† Navarro-López et al. JAMA Dermatol. 2018†††
Micronutrient Synthesis
Bron et al. I J Mol Sciences. 2021 Strozzi & Mogna. J Clin Gastroenterol. 2008 Pompei et al. Appl Environ Microbiol. 2007 Amaretti et al. Appl Microbiol Biotechnol. 2013
Gut Microbial Balance*
Mogna et al. J Clin Gastroenterol. 2012 Drago et al. Allergy Asthma Immunol Res. 2015 Odamaki et al. Anaerobe. 2012† Magistrelli et al. Front Immunol. 2019††
Gut Metabolite Balance
Ogata et al. Biosci Microflora. 1997 Mogna et al. J Clin Gastroenterol. 2014 Tierney et al. Appl Environ Microbiol.2023 Laparra & Sanz. J Cell Biochem. 2010
Benefit
Studies
Digestive Health
Del Piano et al. J Clin Gastroenterol. 2010Ogata et al. Biosci Microflora. 1997Laparra & Sanz. J Cell Biochem. 2010Olivares et al. J Agric Food Chem. 2011
Gut Barrier Integrity
Iemoli et al. J Clin Gastroenterol. 2012 ‡Magistrelli et al. Front Immunol.2019††De Palma et al. J Leukoc Biol. 2012
Gut Immune Axis
Long Yan Fong et al. J Funct Foods. 2016Rodes et al. J Micro Biotech. 2013Olivares et al. J Agric Food Chem. 2011Iemoli et al. J Clin Gastroenterol. 2012‡Drago et al. Allergy Asthma Immunol Res. 2015Magistrelli et al. Front Immunol. 2019††Mogna et al. J Clin Gastroenterol. 2012
Cardiovascular Health
Costabile et al. PLoS One. 2017Bordoni et al. Appl Microbiol Biotechnol. 2013Keleszade et al. J Func Foods. 2022
Dermatological Health
Iemoli et al. J Clin Gastroenterol. 2012‡Climent et al. Microorganisms. 2021†††Navarro-López et al. JAMA Dermatol. 2018†††
Micronutrient Synthesis
Bron et al. I J Mol Sciences. 2021Strozzi & Mogna. J Clin Gastroenterol. 2008Pompei et al. Appl Environ Microbiol. 2007Amaretti et al. Appl Microbiol Biotechnol. 2013
Gut Microbial Balance*
Mogna et al. J Clin Gastroenterol. 2012Drago et al. Allergy Asthma Immunol Res. 2015Odamaki et al. Anaerobe. 2012†Magistrelli et al. Front Immunol. 2019††
Gut Metabolite Balance
Ogata et al. Biosci Microflora. 1997Mogna et al. J Clin Gastroenterol. 2014Tierney et al. Appl Environ Microbiol. 2023Laparra & Sanz. J Cell Biochem. 2010
*: Claim substantiated through in vitro research † : In subjects who are ETBF carriers ‡: In subjects with Atopic Dermatitis (AD) ††: In cells derived from individuals with Parkinson's Disease (PD) †††: In pediatric subjects
DS-01® measures viable cell count in AFU, or Active Fluorescent Units. AFU is measured with flow cytometry, a process where probiotic cells are tagged with fluorescent ‘markers’ and counted by a laser as they pass through a tube. Through AFU, we are able to calculate precise measurement of all viable cells, including ones that are efficacious but not necessarily culturable (and therefore would not be counted in a traditional plated CFU measurement).
CFU stands for Colony Forming Units, and is reflected in plating, a classical microbiology technique that has been used since the 1800s. This technique shows the number of ‘colonies’ that are formed on a plate through a series of dilutions. CFU can vary up to 50% between batch lots, requires different plating ingredients for each species (and sometimes strain), and is best used for single strain, rather than multi-strain synbiotics (including prebiotics).
Globally, there is a lot of discussion about current and future techniques for testing beyond CFU, including flow cytometry and q-PCR (Quantitative Polymerase Chain Reaction), as probiotic strains can vary widely in potency based on biofermentation and production methods (from between 50 Billion AFU / gram to 800 Billion AFU / gram). As a company committed to innovation, we are always evaluating the most effective and precise technologies, including new stabilization techniques, delivery formats, and testing methods.
Today, the use of flow cytometry and its unit of measure (AFU) not only allows us to determine viable cell counts but also allows for the counting of damaged and dead cell subpopulations. Traditional plating techniques (CFU) are limited by parameters of time, specifically the inability to detect viable but nonculturable (VBNC) micro-organisms and nonviable cells. More specifically, AFU detection is equal to or better than CFU for the following reasons: accuracy, precision (repeatability), intermediate precision (ruggedness), specificity, limit of quantification, linearity, range, and robustness.
‡Maximum daily doses are clinically-derived from oral food challenge studies and reflect the most recent advancements in food allergy research. The reference dose, also termed ED01, is the dose at which 1% of the allergic population would be predicted to experience any objective allergic reaction (i.e., 99% of the population does not experience any objectively measurable reaction).
*Inadequate number of clinical studies using low dose oral challenges with this allergen.
Thermostability
Thermostability
Description
Unit of Measure (LOQ)
Testing Frequency
Up to 10 days at 100ºF
≥ Label claim for AFU
2x per year (at minimum)
Up to 2 days at 120ºF
≥ Label claim for AFU
2x per year (at minimum)
Description
Unit of Measure (LOQ)
Testing Frequency
Up to 10 days at 100ºF
≥ Label claim for AFU
2x per year (at minimum)
Up to 2 days at 120ºF
≥ Label claim for AFU
2x per year (at minimum)
Whole Genome Sequencing
Whole Genome Sequencing
Description
Unit of Measure (LOQ)
Testing Frequency
A series of involved genetic tests down to the strain level
≥ Label claim for AFU (strain specific)
Under development
Description
Unit of Measure (LOQ)
Testing Frequency
A series of involved genetic tests down to the strain level
≥ Label claim for AFU (strain specific)
Under development
Water Activity
Water Activity
Description
Unit of Measure (LOQ)
Testing Frequency
(aW) - Dew Point Method
< 0.20 aW (inner and outer cap)
Each batch
Description
Unit of Measure (LOQ)
Testing Frequency
(aW) - Dew Point Method
< 0.20 aW (inner and outer cap)
Each batch
Probiotic Potency (AFU Quantification)
DS-01® measures viable cell count in AFU, or Active Fluorescent Units. AFU is measured with flow cytometry, a process where probiotic cells are tagged with fluorescent ‘markers’ and counted by a laser as they pass through a tube. Through AFU, we are able to calculate precise measurement of all viable cells, including ones that are efficacious, but not necessarily culturable (and therefore would not be counted in a traditional plated CFU measurement).
CFU stands for Colony Forming Units, and is reflected in plating, a classical microbiology technique that has been used since the 1800s. This technique shows the number of ‘colonies’ that are formed on a plate through a series of dilutions. CFU can vary up to 50% between batch lots, requires different plating ingredients for each species (and sometimes strain), and is best used for single strain, rather than multi-strain probiotics, or synbiotics.
Globally, there is a lot of discussion about current and future techniques for testing beyond CFU, including flow cytometry and qPCR (Quantitative Polymerase Chain Reaction), as probiotic strains can vary widely in potency based on biofermentation and production methods (from between 50 Billion AFU / gram to 800 Billion AFU / gram). As a company committed to innovation, we are always evaluating the most effective and precise technologies, including new stabilization techniques, delivery formats, and testing methods.
Today, the use of flow cytometry and its unit of measure (AFU) not only allows us to determine viable cell counts, but also allows us to precisely measure each organism in a complex community or multi-species, multi-strain formulation. Traditional plating techniques (CFU) are extremely variable when enumerating multi-species, multi-strain formulations and are further limited by parameters of time, specifically the inability to detect viable but nonculturable (VBNC) micro-organisms and nonviable cells. More specifically, AFU detection is equal to or better than CFU for the following reasons: accuracy, precision (repeatability), intermediate precision (ruggedness), specificity, limit of quantification, linearity, range, and robustness.
Heavy Metals Testing
Metal
Safe Harbor Levels (mcg/day)
DS-01™ (mcg/day)
% Prop 65 limits in DS-01™
Arsenic
10
0.082
0.82%
Cadmium
4.1
0.029
0.71%
Lead
0.5
0.030
6.07%
Mercury
0.3
0.012
3.93%
Metal
Safe Harbor Levels (mcg/day)
Daily Synbiotic (mcg/day)
% Prop 65 limits in Daily Synbiotic
Arsenic
10
0.082
0.82%
Cadmium
4.1
0.029
0.71%
Lead
0.5
0.030
6.07%
Mercury
0.3
0.012
3.93%
Most supplements, fruits, vegetables, milk-derived proteins, and natural products carry some level of heavy metals, which can be very difficult to completely eliminate from the diet due to their uptake by plants from the surrounding air, water, and soil. Food and natural products are regulated in California by CA Prop 65, or "The Safe Drinking Water and Toxic Enforcement Act of 1986", which establishes "safe harbor levels" for a list of chemicals known to the state to potentially cause cancer or reproductive toxicity. Seed abides by these stringent regulations and tests all products for the four main categories of Heavy Metals: Arsenic, Cadmium, Lead, and Mercury. As demonstrated in the table below, DS-01® falls well below the established limits.
Pesticide Testing
Our product is tested at third party accredited laboratories for over 500 pesticide residues using gas chromatography with tandem mass spectrometry. We [specifically] subject DS-01® to testing for the ubiquitous pesticide, glyphosate, as well as its breakdown product, AminoMethylPhosphonic Acid (AMPA), using liquid chromatography with tandem mass spectrometry. This rigorous testing protocol ensures adherence to our strict quality standards.
The full list of pesticides tested may be viewed here.
Allergen Testing
Each batch of DS-01® is tested and verified free of all 14 classes of allergens according to EFSA.
¹ Almond, Hazelnut, Walnut, Cashew, Pecan Nut, Brazil Nut, Pistachio Nut, Macadamia Nut (also known as Queensland Nut)
* Inadequate number of clinical studies using low dose oral challenges with this allergen.
Digestive Survivability Testing (SHIME®)
To evaluate the survival of our probiotics, we test with a Simulator of the Human Intestinal Microbial Ecosystem (SHIME®)—the closest system developed to model human digestion and the gut. It recreates the physiological conditions and biological processes (food uptake, peristalsis, digestive enzymes, pancreatic and bile acids, and time spent in each step) representative of the human gastrointestinal tract.
Fig. 3 — The SHIME® Process
At the three hour mark of incubation, the ViaCap® delivered a maximal release of probiotics maintaining the full value of the starting dose (10.57 log vs 10.60 log, or about 100%), indicating viability through the end of the small intestine for delivery into the colon. The ViaCap® was engineered for a precision release of the contents of the inner, probiotic capsule, through the small intestine, resulting in full delivery of label potency prior to entering the colon chamber.
Thermostability Testing
Heat typically injures or kills living probiotics, but the selection of probiotic strains and the delivery system that carries them (think: capsules, powders, liquid fill) each respond differently to varying levels of heat exposure. We've tested our strains and ViaCap® capsule-in-capsule delivery system mimicking the packaging and worst-case scenario heat conditions that DS-01® could potentially encounter on its way to our customers.
Even after 10 days of constant, 24 hour, 100º F exposure, which is very unlikely even in the heat of summer, our probiotic bacteria counts and viability exceeded the living cell counts (AFU) stated on our label.
Only with constant exposure to blazing temperatures of 120ºF—continuously over 48 hours—did the total biopotency of the DS-01® dip below label claim numbers and requirements.
Interactions
DS-01® is safe to take with other supplements and there are no known contraindications with medications. We would recommend that you also consult with your personal physician in regards to your prescription medications so that they may advise with the complete knowledge of your health history.
Can I take too many probiotics?
Unlike with some vitamins and minerals, probiotics do not have recommended upper limits and have not been shown to reach levels of toxicity. In fact, probiotics have been clinically studied for certain indications in CFU dosages that reach the trillions. It is important to note, more is not necessarily better—the best dose per strain of probiotics is the dose that has been shown in human clinical trials to have the intended health benefit.
Can I take DS-01® with other probiotics?
DS-01® is safe to take with other supplements, including another probiotic. There may be some functional redundancy if combining our probiotic with other microbial strains in the Lactobacillus and Bifidobacteria genera, but it will not hurt to do so.
Reference Library
Formulation
Supplement Facts
Serving Size 2 Capsules Servings Per Container 30
Amount Per Serving
ViaCap®• Probiotic Inner Capsule
Digestive Health / Gut Immunity / Gut Barrier Integrity Probiotic Blendº
Daily Value (DV) is based on a 2000 calorie diet. * Daily Value not established.
‡AFU = Active Fluorescent Units (indicator of probiotic viable cell count)
Other Ingredients: Acid-Resistant Vegan Outer [chlorophyllin] and Inner [hypromellose, water] Capsules, organic rice fiber, organic rice extract blend.
For Optimal Results: Take 2 capsules at once, daily, ideally on an empty stomach. No refrigeration necessary.
Women who are pregnant or planning a pregnancy should consult their doctor before taking supplements. Keep out of reach of children. Do not use if seal is broken.
Developed by Seed Health, Inc., Venice, CA 90291. Seed®, DS-01®, and ViaCap® are registered trademarks, and MAPP Microbiota-Accessible Polyphenolic Precursors™ is a trademark of Seed Health, Inc.
º These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Additional Info
What is this label for?
This is the Supplement Facts Label. Currently, in the United States, probiotics and prebiotics are classified as supplements. Unfortunately, this also means they are more loosely regulated than foods or drugs. While we adhere to all FDA requirements, we actually look to meet and surpass more stringent global standards, such as EFSA in Europe and FOSHU in Japan.
Nevertheless, this Supplement Facts label tells you a lot of useful information about the contents of DS-01®. We know these things are sometimes confusing, so let’s go through it together.
What’s the difference between a Supplement Facts label and a Nutrition Facts label?
The FDA is in charge of regulating both food and dietary supplements, and each category gets its own label and different labeling requirements. Since there’s no established daily value for many supplements, the Supplements Facts label must indicate the ingredients and quantities for each.
What is the ViaCap® delivery technology?
Our 2-in-1 nested capsule houses the inner probiotic capsule, inside the outer prebiotic capsule. This delivery system shields against stomach acid, digestion enzymes, and bile salts, and safeguards viability through digestion, for delivery of an average of 100% of our probiotic starting dose to your colon. The outer capsule also serves as an elegant barrier to oxygen, moisture, and heat—no refrigeration necessary.
Why do I have to take 2 capsules every day?
Two capsules = the research-derived dose. In other words, when a study on a probiotic strain (or anything else) demonstrates a benefit, the same dose used in the study must also be translated into the product you take. We formulated the strains in your DS-01® in alignment with the clinically and scientifically studied doses. Together, they form the full dose of two capsules.
What does AFU mean?
We test for AFU (Active Fluorescent Units)—an advanced and precise enumeration method for probiotics today. These are measured through flow cytometry, a process where probiotic cells are tagged with fluorescent ‘markers’ and counted by a laser as they pass through a tube. Through AFU, we are able to calculate a more precise measurement of all viable cells, including ones that are efficacious but not necessarily culturable (and therefore would not be counted in a traditional plated CFU measurement—what you’re probably used to seeing on probiotics labels).
If you’re not familiar, CFU stands for Colony Forming Units, and is reflected in plating, a classic microbiology technique that has been used since the 1800s. This technique shows the number of ‘colonies’ that are formed on a plate through a series of dilutions. While it remains the industry standard, CFU is not an exact science. It can vary widely between batch lots, can be ineffective for multi-strain probiotics, as different strains of bacteria often require different growth media.
What do these letters and numbers indicate?
The letters and numbers designate the strain. For example, in Bifidobacterium breve SD-BR3-IT, ‘Bifidobacterium’ is the genus, ‘breve’ is the species, and ‘SD-BR3-IT’ is the strain specification.
Why is strain specificity important? Well, precision is critical, especially with bacteria. Within each species, there are actually multitudes of strains. Just like a french bulldog is quite different from a golden retriever (even though they both belong to the genus and species Canis lupus familiaris), each strain of a bacterial species has its own characteristics and cannot be lumped together synonymously. As an example, Lactobacillus plantarum 299v has been shown to effectively reduce IBS symptoms in a number of trials, whereas administration of Lactobacillus plantarum MF1298 was actually found to worsen them.
In selecting a probiotic, look for full strain names on the label, and then ask for the clinical studies and research that support each strain and the benefits it claims to confer.
What does the Seed Digestive Health / Gut Immunity / Gut Barrier Integrity Probiotic Blend do?
Gastrointestinal Health
• Promotes digestive health (to support healthy regularity and ease of bloating)†
• Reinforces healthy stool hydration and ease of evacuation†
• Supports gut ease from occasional gastrointestinal discomfort associated with increased intestinal transit time†
Gut Immune Function
• Supports healthy gut immune function and 'cross-talk' between immune and intestinal cells*
• Maintains healthy immunological responses in the gastrointestinal tract*
• Supports production of short-chain fatty acids*
Gut Barrier Integrity
• Maintains healthy gut barrier function and integrity*
• Reinforces healthy tight junction function in vitro*
• Supports healthy gut barrier integrity from ethanol- and endotoxin-induced (lipopolysaccharide) permeability in vitro*
What does the Seed Dermatological Health Probiotic Blend do?
Formulated with strains that:
• Promote healthy skin*
• Reinforce healthy gut-skin axis*
What does the Seed Cardiovascular Health Probiotic Blend do?
Formulated with strains that:
• Promote heart health*
• Help maintain blood cholesterol levels already in the normal range*
• Support healthy intestinal recycling of cholesterol and bile*
What does the Seed Micronutrient Synthesis Probiotic Blend do?
Formulated with strains that:
• Support folate (vitamin B9) production via intestinal synthesis of bioactive forms of folate*
• Support intestinal synthesis of vitamin B12 in vitro*
Where is Seed’s prebiotic sourced from?
While most prebiotics today fall into the category of dietary fibers such as fructo-oligosaccharides (FOS) and galacto-oligosaccharides (GOS), or inulin, our Microbiota-Accessible Prebiotic [MAP] introduces a patented, plant-based, non-fermenting prebiotic compound (punicalagin) concentrated from Indian pomegranate. Punicalagin is further biotransformed by gut bacteria into beneficial metabolites for the body.
What are these ‘Other Ingredients’?
Our 100% vegan capsule is made of hypromellose (instead of gelatin), gellan gum (which is actually produced through bacterial fermentation), chlorophyllin, and organic rice fiber and extract. Our ViaCap® 2-in-1 capsule system shields our probiotics in their journey through digestive acids and enzymes, to deliver live strains to your colon.
Reference Library
Share
Share the DS-01®️ fact sheet with your healthcare practitioner.
