We believe in full transparency, use of the best methods, equipment, personnel, tools and customer service to bring you the most tested and effective solutions for microbiota reconstruction.
Other stool banks use donations from individuals who are only screened at the time of donation and relying largely on a questionnaire. Both the age and gender of the donors is not considered, and often the samples are 'blended' together. This is counter-indicated to creating the best donor samples. Research has shown that male and female microbiomes are significantly different, and this could potentially be critical for women who are pregnant or expecting to be. Further, the age of the donor largely determines specimen quality (the younger the better, even to toddler and/or infant age), as does past antibiotic use, diet and genetic predispositions. Despite these low standards and lack of any third party verification, many other banks will simply describe a 'profile' e.g. "eats organic", but does not verify how this was determined. Our donors are <10 years old and their samples are screened far beyond these standard parameters, see below. And, our samples are not 'blended' or 'pooled', and we offer gender-specific options.
Our primary donors are no more than 10 years old. We verify their medical histories for illness and if possible, family genetic histories. We verify their diets, and verify and evaluate other factors such as intelligence, physical and behavioral health against peers and use a high degree of exclusionary criteria. We also make sure to verify donors have not had any vaccinations of any type. And, we offer gender-specific donor media. For additional exclusionary criteria, any donor with a Body Mass Index (BMI) >30kg/m2, history of Metabolic syndrome, any history of antibiotics use in the last 6 months, history of diarrhea within the last 12 months, history of clostridioides difficile colitis (c. diff.), history of immune disorder or use of any immunosuppressive medications, any risk factor for HIV (Human Immunodeficiency Virus) or viral hepatitis, history of travel to a tropical region in the last 6 months, history of gastrointestinal illness (IBD, Inflammatory Bowel Disease; IBS, Irritable Bowel Syndrome, gastrointestinal malignancy, or major surgery) or complaints, any history of chronic pain syndrome (fibromyalgia, chronic fatigue syndrome), any history of neurologic or neuro-developmental disorders, history of any fungal or yeast infection, or any history of malignancy. We use a third party laboratory to perform screening and verification of the following:
BACTERIAL SCREENING
Via blood: Treponema spp.
Via stool: Enteric pathogen culture: Salmonella, Shigella, Campylobacter spp., Helicobacter pylori – EIA
VRE antibiotic sensitivity test to prevent the use of stool containing polyresistant strains.
VIRAL SCREENING
Via blood: Hepatitis A virus IgM, Hepatitis B virus surface antigen, Anti-hepatitis C virus, HIV 1 and 2
Via stool: Norovirus EIA or PCR, Rotavirus EIA
PARASITIC SCREENING
Via blood: Entamoeba histolytica, Strongyloides stercoralis
Via stool: Ovum and parasite, Microsporidia, Ghardia faecal antigen/EIA, Cryptosporidium EIA, AFB for Isospora and Cyclospora
OTHER TESTS PERFORMED
Complete blood count, Liver function test, ESR and CRP, Clostridium difficile test, PCR of toxin genes
DONOR FECAL SAMPLE TEST VERIFICATION
We also verify the samples meet our standards for desired bacteria and microbe strains, ratios, diversity and density, independently certified at 0,36 x 10 Billion (+/- 5%) bacteria and variability superior to 60%.
Specimens are collected from the donors in Covidien pans and then transferred into a sterile container with a single use sterile plastic instrument. The donated stool is processed within thirty minutes of production by the donor. Any reusable tools are sterilized with ethylene oxide. 200 ml of sterile physiological saline solution (0.9% sodium chloride) is added to 60 g of the sample and the stool is homogenized. The solution is then filtered with a medical fine-mesh nylon strainer to eliminate any larger particulate. The resulting preparation volume is approximately 220 mL. This volume is then placed in 50 ml tubes and centrifuged for 10 minutes to eliminate the smaller particulate. The slurry is discarded, and the supernatant is handled in 60 mL portions. With these steps, approximately 120 mL of macroscopically homogenous solution can be made from 60 g of initial stool sample. This procedure is carried out under anaerobic conditions in a dedicated cabinet on room temperature immediately after the donor sample is collected.
CAPSULES
A secondary centrifuge step to achieve a bacteria-rich sediment, which is then combined with maltodextrin to produce a viscous paste. The paste is then loaded into 500mg size 00 capsules and frozen until use.
LYOPHILIZED
The supernatant is lyophilized, loaded into sterile glass container with a vacuum seal and frozen until use.
CLYSTER
The supernatant is combined with additional sterile physiological saline solution (0.9% sodium chloride) and loaded into a 60ml syringe and frozen until use.
We cryogenically store our finished samples at 20 degrees F, which is optimum in terms of both preventing quantitative changes to beneficial Bacteroides and Clostridium species while concurrently preserving paramount engrafting spore formation bacterium.
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