Reference

Formulation

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

*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 500+ 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

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.

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.

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.

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® was applied to 2 versions of the SHIME® model, simulating fasted and fed conditions. The long exposure to low pH under fasted conditions appeared detrimental to the bacterial cells, resulting in 1.59% survival of the live cells present in the product. By contrast, 70.2% of the bacterial cells survived the much less harsh stomach conditions in the fed-simulating SHIME® model. These results suggest that consuming PDS-08® in a fed state is superior in promoting gastrointestinal survivability.  

It is important to note that these data suggest a different mode of consumption compared to DS-01®, which we recommend is taken on an empty stomach. This disparity is the result of different delivery technologies: the free flowing powder in PDS-08®, and the nested ViaCap® in DS-01®. The ViaCap® was designed to shield against digestion and is most effective when consumed in a fasted state, rather than immediately after a meal when digestive enzymes and bile salts would be at a higher level. Conversely, our powdered formulation with microencapsulated strains exhibited a much higher survivability rate in a fed state because of the reduced exposure to, and intensity of, acidic conditions because of the buffer that a meal provides.

Interactions

There are no known contraindications with 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.