PDS-08™ comprises 9 clinically-studied probiotic strains with a dual-phase prebiotic. This breakthrough formulation is paired with innovations in probiotic stabilization and precision release to deliver strains to the lower small intestine in children to support gut and systemic benefits, including digestive, skin, and respiratory health. Non-stimulant and non-habit-forming.

Formulation

Lacticaseibacillus rhamnosus SD-GG-IT

Lactobacillus acidophilus SD-NCFM-US 

Bifidobacterium lactis SD-Bi07-US 

Bifidobacterium breve SD-BR3-IT

Bifidobacterium breve SD-B632-IT 

Ligilactobacillus salivarius SD-LS01-IT 

Bifidobacterium lactis SD-CECT8145-SP 

Bifidobacterium longum SD-CECT7347-SP

Lacticaseibacillus casei SD-CECT9104-SP 

Molecular weight profiled inulin and fructooligosaccharides.

Directions for Use

Consistent, daily use is important to activate the PDS-08™ benefits for your child. 

That’s why each component of the PDS-08™ experience is designed with simplicity and “how-do-I-get-my-kid-to-do-this-daily” ¹ in mind.

Pour 1 sachet into room temperature food or drink. 

Bacteria are fragile—to preserve viability, mix powder into a cold or room temperature soft food (yogurt, fruit puree) or liquid (water, milk).

Mix well until fully dissolved.

Stir powder into food until well distributed. If mixing into liquid, be sure to shake well in a closed bottle. Please do not use a blender or food processor. Once mixed, do not heat food or drink.

Try to consume the full dose within 30 minutes. 

Once powder is in contact with food or drink, consume as soon as possible to optimize the full benefits.

Repeat and track, daily.

To ensure your child doesn’t miss a day, twist the BacTrac™ container top to align the dot (•) and day so you always remember the last date of use.

Just as with any new diet, product, or lifestyle change, your child may experience a temporary acclimation period—some gastrointestinal discomfort, abdominal tightness, mild nausea, or changes in their stool. This is normal. 

If you know your child is prone to digestive sensitivity, we recommend starting with a half dose for the first 3-5 days. When ready, increase to the full dose of one sachet, daily. Place the unused half sachet into an airtight bag, and then use the next day.

¹ While probiotics are a science, parenting is not—however your child prefers to take PDS-08™ each day, that is the best way.

Clinical Trials

PDS-08™ in Pediatric Bowel Function  

Our mission to steward the next generation of probiotics continues with PDS-08™—our first pediatric innovation. 

PDS-08™ Pediatric Daily Synbiotic is our proprietary 2-in-1 powdered synbiotic with 9 clinically studied probiotic strains and over 6 grams of our mixed-chain length prebiotic blend. It’s been studied in a pediatric population and formulated for benefits in and beyond the gut. 

The composition of the human gut microbiome has been identified as playing a role in regulating bowel movements in children. Pediatric subjects can experience infrequent bowel movements and associated phenotypes therein (e.g. stool consistency, pain when defecating, bloating). Constipation afflicts about 25% of children visiting pediatric gastroenterologist practices in the United States. Symptoms of pediatric FC frequently persist into adolescence and adulthood despite treatment with laxatives, indicating the need for alternative paradigms to regulate bowel movement frequency.

The objective of our study was to measure the impact of PDS-08 on Weekly Bowel Movements (WBMs) in children with low bowel movement frequency, compared to a placebo. Sixty-four children (3-17 years of age) were randomized to receive PDS-08 (n=33) or placebo (n=31) for 84 days. Stool microbiota was analyzed using shotgun metagenomic sequencing on samples collected at baseline (T1) and completion (T2). Children with low bowel movement frequency administered PDS-08 significantly increased in number of WBMs.. The product was safe and well tolerated, with no adverse events reported. Bacterial strains from PDS-08 were detectable at high concentrations in individuals who received treatment. These individuals also had an overall increase in Bifidobacterium abundance, known in the scientific literature as a bifidogenic effect. These findings suggest the potential for multi-species synbiotic interventions to support  digestive health and function in a pediatric population.

Strain-Specific Benefit Studies

BenefitStudies
Digestive Health*Gawronska, A. et al. Aliment Pharmacol Ther. 2007Francavilla, R. et al. Pediatrics, 2010Canani, R. B. et al. BMJ. 2007Korpela, K. et al. PLoS One. 2016Li, Y. T. et al. World J Gastroenterol. 2019Chen, K. et al. Benef Microbes. 2020
Skin Health*Niccoli, A. A. et al. J Clin Gastroenterol. 2014Navarro-López, V., et al. JAMA Dermatol. 2018Reddel, S. et al. Sci Rep. 2019
Gut Immune Function*Medina, M. et al. J Inflamm (Lond). 2008Kara, S. S.,et al. Benef Microbes. 2019DeMuri, G. P., et al. Benef Microbes. 2021
Gut Barrier Integrity*Olivares, M.et al. J Agric Food Chem. 2011Sindhu, K. N. et al. Clin Infect Dis. 2014
Respiratory Health*Leyer, G. J. et al. Pediatrics. 2009Drago, L. et al. J Immunol Res. 2022Laursen, R. P. et al. Eur J Pediatr. 2018Ouwehand, A. C. et al. World J Gastroenterol. 2009
BenefitStudies
Digestive HealthGawronska, A. et al. Aliment Pharmacol Ther. 2007Francavilla, R. et al. Pediatrics, 2010Canani, R. B. et al. BMJ. 2007Korpela, K. et al. PLoS One. 2016Li, Y. T. et al. World J Gastroenterol. 2019Chen, K. et al. Benef Microbes. 2020
Skin HealthNiccoli, A. A. et al. J Clin Gastroenterol. 2014Navarro-López, V., et al. JAMA Dermatol. 2018Reddel, S. et al. Sci Rep. 2019
Gut Immune FunctionMedina, M. et al. J Inflamm (Lond). 2008Kara, S. S.,et al. Benef Microbes. 2019DeMuri, G. P., et al. Benef Microbes. 2021
Gut Barrier IntegrityOlivares, M.et al. J Agric Food Chem. 2011Sindhu, K. N. et al. Clin Infect Dis. 2014
Gut Barrier IntegrityOlivares, M.et al. J Agric Food Chem. 2011Sindhu, K. N. et al. Clin Infect Dis. 2014
Respiratory HealthLeyer, G. J. et al. Pediatrics. 2009Drago, L. et al. J Immunol Res. 2022Laursen, R. P. et al. Eur J Pediatr. 2018Ouwehand, A. C. et al. World J Gastroenterol. 2009

*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.

Testing

We conduct extensive testing on PDS-08™ throughout each step of the manufacturing process as well as on the final product. This includes whole-genome sequencing on our strains (translation: we know which strains are present and in which quantities), flow cytometry to measure and enumerate viable cells, survivability testing to ensure that our probiotics survive the trip through your GI tract, heat and humidity testing to mimic the most extreme conditions our product may encounter during shipping, and over 50 quality assurance and quality control (QA/QC) checkpoints. 

The final product is tested for 420 different pesticides (including glyphosate), and 14 of the most common allergens as defined by the EFSA. Our probiotic strains have GRAS and/or QPS status, which designates them as safe for consumption by the United States and European Union, respectively.

We monitor purity under both US and European protocols (including cGMP + HACCP) throughout the production cycle with no skip-lot testing (this means, we test each ingredient batch prior to encapsulation and each batch after manufacture).

Quality Control Testing Battery

Microbiological DataDescriptionUnit of MeasureTesting Frequency
Yeasts and molds<100 CFU/gEach batch
Enterobacteria<10 MPN/gEach batch
Total coliforms<3 MPN/gEach batch
E. coliAbsent/ 10 gEach batch
SalmonellaAbsent/ 25 gEach batch
Staphylococcus coagulase positive<10 CFU/gEach batch
Listeria monocytogenesNegative/ 25 gEach batch
DescriptionUnit of Measure (LOQ)Testing Frequency
Yeasts and molds<100 CFU/gEach batch
Enterobacteria<10 MPN/gEach batch
Total coliforms<3 MPN/gEach batch
E. coliAbsent/ 10 gEach batch
SalmonellaAbsent/ 25 gEach batch
Staphylococcus coagulase positive<10 CFU/gEach batch
Listeria monocytogenesNegative/ 25 gEach batch
Probiotic PotencyDescriptionUnit of MeasureTesting Frequency
Sum total of all viable Seed PDS-08™ strainsAFU/g (Active Fluorescent Units)Each batch
DescriptionUnit of Measure (LOQ)Testing Frequency
Sum total of all viable Seed PDS-08™ strainsAFU/g (Active Fluorescent Units)Each batch
Chemical Contaminants
Heavy Metals [Inorganic]
DescriptionUnit of MeasureTesting Frequency
Arsenic<0.01 ppm (parts per million)Each batch
Lead<0.01 ppm (parts per million)Each batch
Cadmium<0.01 ppm (parts per million)Each batch
Mercury<0.01 ppm (parts per million)Each batch
DescriptionUnit of Measure (LOQ)Testing Frequency
Arsenic<0.01 ppm (parts per million)Each batch
Lead<0.01 ppm (parts per million)Each batch
Cadmium<0.01 ppm (parts per million)Each batch
Mercury<0.01 ppm (parts per million)Each batch
Chemical Contaminants
[Organic]
DescriptionUnit of MeasureTesting Frequency
AMPA (breakdown product of glyphosate)<10.0 ppb (parts per billion)Each batch
Glyphosate<10.0 ppb (parts per billion)Each batch
Pesticides/Biocides [>400 (402, to be exact) different chemicals]<0.01 ppm (parts per million); see Pesticides List in Apendix Section IIIEach batch
DescriptionUnit of Measure (LOQ)Testing Frequency
AMPA (breakdown product of glyphosate)<10.0 ppb (parts per billion)Each batch
Glyphosate<10.0 ppb (parts per billion)Each batch
Pesticides/Biocides [>400 (402, to be exact) different chemicals]<0.01 ppm (parts per million); see Pesticides List in Apendix Section IIIEach batch
AllergensDescriptionUnit of Measure (ppm or Limit Of Quantitation)Testing Frequency
Almond<2.5 ppmEach batch
Brazil NutNegativeEach batch
Crustaceans<0.05 ppmEach batch
Egg<2.5 ppmEach batch
FishNegativeEach batch
Gluten [across barley, rye, + wheat]<5.0 ppmEach batch
Macadamia NutNegativeEach batch
Milk<2.5 ppmEach batch
PeanutNegativeEach batch
PecanNegativeEach batch
PistachioNegativeEach batch
Soy<2.5 ppmEach batch
Walnut<2.4 ppmEach batch
Hazelnuts<2.5 ppmEach batch
CashewsNegativeEach batch
Pine Nuts<1.0 ppmEach batch
CeleryNegativeEach batch
Mustard<1.0 ppmEach batch
Sesame Seeds<2.5 ppmEach batch
Sulphite<8.0 ppmEach batch
Lupin<1.0 ppmEach batch
CornNegativeEach batch
MollusksNegativeEach batch
AllergensDescriptionUnit of Measure (ppm or Limit Of Quantitation)Testing Frequency
Almond<2.5 ppmEach batch
Brazil NutNegativeEach batch
Crustaceans<0.05 ppmEach batch
Egg<2.5 ppmEach batch
FishNegativeEach batch
Gluten [across barley, rye, + wheat]<5.0 ppmEach batch
Macadamia NutNegativeEach batch
Milk<2.5 ppmEach batch
PeanutNegativeEach batch
PecanNegativeEach batch
PistachioNegativeEach batch
Soy<2.5 ppmEach batch
Walnut<2.4 ppmEach batch
Hazelnuts<2.5 ppmEach batch
CashewsNegativeEach batch
Pine Nuts<1.0 ppmEach batch
CeleryNegativeEach batch
Mustard<1.0 ppmEach batch
Sesame Seeds<2.5 ppmEach batch
Sulphite<8.0 ppmEach batch
Lupin<1.0 ppmEach batch
CornNegativeEach batch
MollusksNegativeEach batch

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 SurvivabilityDescriptionUnit of MeasureTesting Frequency
Simulated Human Intestinal Microbial Ecosystem [SHIME®]≥ 90% survival2x per year (at minimum)
DescriptionUnit of MeasureTesting Frequency
Simulated Human Intestinal Microbial Ecosystem [SHIME®]≥ 90% survival2x per year (at minimum)
ThermostabilityDescriptionUnit of Measure (≥ label claim AFU)Testing Frequency
Up to 10 days at 100ºF≥ Label claim for AFU2x per year (at minimum)
Up to 2 days at 120ºF≥ Label claim for AFU2x per year (at minimum)
DescriptionUnit of Measure (≥ label claim AFU)Testing Frequency
Up to 10 days at 100ºF≥ Label claim for AFU2x per year (at minimum)
Up to 2 days at 120ºF≥ Label claim for AFU2x per year (at minimum)
Whole Genome SequencingDescriptionGenBank Number SimilarityTesting Frequency
A series of involved genetic tests down to the strain level≥ Label claim for AFU (strain specific)Under development
DescriptionGenBank Number similarityTesting Frequency
A series of involved genetic tests down to the strain level>99% similarityUnder development
Water ActivityDescriptionUnit of Measure (aW)Testing Frequency
(aW) - Dew Point Method< 0.20 aWEach batch
DescriptionUnit of Measure (aW)Testing Frequency
(aW) - Dew Point Method< 0.20 aWEach batch

Probiotic Potency (AFU Quantification)

PDS-08™ 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.

Heavy Metals Testing

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, PDS-08™ falls well below the established limits.

MetalSafe Harbor Levels (mcg/day)PDS-08™ (mcg/day)% Prop 65 limits in PDS-08™
Arsenic100.020.2%
Cadmium4.10.071.7%
Lead0.50.0714.0%
Mercury0.30.0723.3%

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 PDS-08™ for the 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 PDS-08™, at a limit of quantitation of 10 parts per billion. 

The full list of pesticides tested may be viewed here.

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 PDS-08™ strains mimicking the packaging and worst-case scenario heat conditions that PDS-08™ could potentially encounter on its way to our customers.

Even after 10 days of constant, 24 hour, 120º 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.

PDS-08™ Heat Sachet Test
PDS-08™ Heat Sachet Test

Humidity Testing

We’ve tested PDS-08™ for potency and powder flow characteristics at high humidity--the enemy of powder and which can cause "clumping". After 28 days of constant exposure to extremely humid conditions (80% relative humidity, at room temperature ≈ 72 ºF), the PDS-08™ AFU values exceeded label claims indicating that our product remains highly viable when exposed to sustained high humidity. Furthermore, through the entire duration to Day 28, the powder exhibited free-flowing physical characteristics with no clumping.

PDS-08™ Humidity Sachet Test
PDS-08™ Humidity Sachet Test
PDS-08™ Humidity Sachet/BacTrac™ Test
PDS-08™ Humidity Sachet/BacTrac™ Test

Interactions

There are no known contraindications with the PDS-08™ and medications, therefore PDS-08™ would be generally safe to take alongside any other prescription or over-the-counter medications. 

However, if undergoing a course of antibiotics, it may be prudent to space the antibiotics out as far from the probiotics as possible—i.e. one in the morning and one in the evening. For context, probiotics are beneficial organisms that are also susceptible to being killed off by antibiotics which is why we generally recommend trying to separate intake as much as possible.

We would recommend that you also consult with a doctor or family physician in regards to any prescription medications so that they may advise with the complete knowledge of your child's health history.