Reference

Formulation

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.

Clinical Trials

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

*: 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

Quality Control Testing Battery

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.

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.

We specifically test each batch of DS-01™ 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 the Daily Synbiotic, at a limit of quantitation of 10 parts per billion.

The full list of pesticides tested may be viewed here.

DS-01® is tested for all 14 classes of allergens according to EFSA and verified to be below the ED01.

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.

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.