Reference
DS-01® Daily Synbiotic
Overview
Formulation
Directions for Use
Clinical Trials
Strain-Specific Benefit Studies
Testing
Interactions
Share
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
37.0 Billion AFU
Bifidobacterium longum SD-BB536-JP
Bifidobacterium breve SD-BR3-IT
Lactiplantibacillus plantarum SD-LP1-IT
Lacticaseibacillus rhamnosus SD-LR6-IT
Lacticaseibacillus rhamnosus HRVD113-US
Bifidobacterium infantis SD-M63-JP
Bifidobacterium lactis SD-BS5-IT
Bifidobacterium lactis HRVD524-US
Lactobacillus crispatus SD-LCR01-IT
Lacticaseibacillus casei HRVD300-US
Bifidobacterium breve HRVD521-US
Bifidobacterium longum HRVD90b-US
Bifidobacterium lactis SD150-BE
Limosilactobacillus fermentum SD-LF8-IT
Lacticaseibacillus rhamnosus SD-GG-BE
Limosilactobacillus reuteri RD830-FR
Dermatological Health Probiotic Blend
3.3 Billion AFU
Bifidobacterium lactis SD-CECT8145-SP
Bifidobacterium longum SD-CECT7347-SP
Lacticaseibacillus casei SD-CECT9104-SP
Ligilactobacillus salivarius SD-LS1-IT
Bifidobacterium breve SD-BR3-IT
Cardiovascular Health Probiotic Blend
5.25 Billion AFU
Lactiplantibacillus plantarum SD-LPLDL-UK
Bifidobacterium lactis SD-MB2409-IT
Micronutrient Synthesis Probiotic Blend
8.05 Billion AFU
Lactiplantibacillus plantarum SD-LPLDL-UK
Bifidobacterium lactis SD-MB2409-IT
Microbiota-Accessible Polyphenolic Precursors™ [MAPP] 400mg
400mg
Lactiplantibacillus plantarum SD-LPLDL-UK
Bifidobacterium lactis SD-MB2409-IT
How to Read Our Label
Directions for Use
Take 1 capsule daily for the first three days.
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
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
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 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
*: 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
1
2
3
Fig. 2 — Strain microscopy: 1 Lactobacillus rhamnosus SD-LR6-IT, 2 Lactobacillus plantarum SD-LPLDL-UK, 3 Bifidobacterium longum SD-CECT7347-SP
Testing
Quality Control Testing Battery
Microbiological Data
Description
Unit of Measure (LOQ)
Testing Frequency
Yeasts and molds
<100 CFU/g
Each batch
Enterobacteria
<10 MPN/g
Each batch
Total coliforms
<3 MPN/g
Each batch
E. coli
Absent/ 10 g
Each batch
Salmonella
Absent/ 25 g
Each batch
Staphylococcus coagulase positive
<10 CFU/g
Each batch
Staphylococcus coagulase positive
<10 CFU/g
Each batch
Listeria monocytogenes
Negative/ 25 g
Each batch
Probiotic Potency
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.
Probiotic Potency
Description
Unit of Measure (LOQ)
Testing Frequency
All Seed DS-01™ strains
AFU/g (Active Fluorescent Units)
Each batch
Chemical Contaminants
Heavy Metals [Inorganic]
Description
Unit of Measure (LOQ)
Testing Frequency
Arsenic
<1 ppm (parts per million)
Each batch
Lead
<3.0 ppm
Each batch
Cadmium
<1.0 ppm
Each batch
Mercury
<0.10 ppm
Each batch
Chemical Contaminants
[Organic]
Description
Unit of Measure (LOQ)
Testing Frequency
AMPA (breakdown product of
glyphosate)
<10.0 ng/g
Quarterly
Glyphosate
<10.0 ng/g
Quarterly
Pesticides/Biocides [427
different chemicals]
Varies; see Pesticides List in
Appendix Section III
Quarterly
Allergens
Description
Unit of Measure (LOQ)
Testing Frequency
Almond
<2.5 ppm (parts per million)
Quarterly
Brazil Nut
Negative
Quarterly
Crustaceans
<0.05 ppm
Quarterly
Crustaceans
<0.05 ppm
Quarterly
Egg
<2.5 ppm
Quarterly
Fish
Negative
Quarterly
Gluten [across barley, rye, oats
+ wheat]
<5.0 ppm
Quarterly
Macadamia Nut
Negative
Quarterly
Milk
<2.5 ppm
Quarterly
Peanut
Negative
Quarterly
Pecan
Negative
Quarterly
Digestive Survivability
Description
Unit of Measure (LOQ)
Testing Frequency
Simulated Human Intestinal
Microbial Ecosystem [SHIME®]
≥ 90% survival
2x per year (at minimum)
Disintegration
<30 minutes
Each batch
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)
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
Water Activity
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%
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
Each batch of our final product is tested at third party accredited laboratories for over 400 pesticide residues using gas chromatography with tandem mass spectrometry. Testing certifies that each of the evaluated chemicals is absent or below the limit of quantitation of 0.010 mg/kg.
We specifically test each batch of DS-01® for the ubiquitous pesticide Glyphosate as well as its breakdown product, AminoMethylPhosphonic Acid (AMPA), using liquid chromatography with tandem mass spectrometry. Results show that glyphosate and AMPA are undetectable in the DS-01®, at a limit of quantitation of 10 parts per billion.
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.
Allergen
DS-01™
Daily Dose
Reference Dose
(in milligrams of protein)
Cashews
undetectable; below limit of quantitation
0.5 milligrams
Celery
undetectable; below limit of quantitation
0.07 milligrams
Gluten
undetectable; below limit of quantitation
0.7 milligrams (wheat
protein)
Crustaceans
undetectable; below limit of quantitation
26.2 milligrams
(shrimp protein)
Eggs
undetectable; below limit of quantitation
0.2 milligrams
Fish
undetectable; below limit of quantitation
2.6 milligrams
Hazelnut
undetectable; below limit of quantitation
0.1 milligrams
Lupin
32-34 micrograms (0.4 - 0.43% of the
Reference Dose)
2.9 milligrams (or 4,000
micrograms)
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.