Custom Spore Complete

Custom Spore Complete is a unique spore-based, broad-spectrum probiotic formula designed to promote a healthy gut microbiota, support gastrointestinal (GI) health, and support immune function. Ortho Spore Complete is specifically formulated with several spore-based probiotic strains to promote diversity and balance within the host gut microbiota. Each capsule provides key Bacillus strains that remain in a dormant, protective state in the harsh GI environment, then become active on target to transiently re-establish and recondition the gut.

Overview
A healthy GI tract is a finely balanced environment where countless microbes compete for space and nutrients. Under conditions of health, the ecosystem is balanced (eubiosis), and few GI and extra-intestinal symptoms exist. However, dysbiosis can occur when an overabundance of potentially harmful organisms prevails. Therefore, the health of the GI tract relies on balanced microbiota. Probiotics contribute to balance by positively influencing the intestinal environment via pH balance, microorganism diversity, and immune signaling. The natural microbiota balance can be upset by numerous lifestyle factors such as medications, excessive alcohol consumption, low stomach acid, or poor diet.

Probiotics have been extensively studied and characterized by having broad GI and immune benefits. These include supporting the population of healthy commensal microbes following microbiota imbalance; supporting healthy bowel function; increasing the production of short-chain fatty acids, which provide energy to the cells of the intestinal lining; strengthening the gut-immune barrier by promoting a healthy gut mucosa; enhancing detoxification of harmful compounds; and aiding in the digestion of compounds like lactose and casein. Probiotics are live organisms and must be shelf-stable through the expiration date, so they can be precisely delivered to the intestinal tract and have maximum benefit.

Bacillus spores transition between a dormant and an active, vegetative form, depending on the environment. Bacillus spores remain dormant in harsh environments until they reach more favorable environments like the human GI tract. In its dormant spore form, Bacillus surrounds itself with an endospore. The endospore is a tough, natural outer shell that protects it from light, heat, pressure, acid, lack of oxygen, and other environmental factors. The Bacillus spore transitions to its active, vegetative form in the large intestine. The vegetative form can then transiently colonize the gut. In its active form, Bacillus probiotics can increase microbial diversity by changing the local pH and increasing the production of short-chain fatty acids. The combination of specific Bacillus probiotic species, particularly Bacillus coagulans, Bacillus clausii, and Bacillus subtilis, relieve symptoms for common GI complaints and reinforce healthy gut function.

Bacillus coagulans (strains MTCC 5856 [LactoSpore®] and SNZ 1969)
Bacillus coagulans supports a balanced microbiota by having antagonistic effects against unwanted organisms and supporting healthy commensal microbes. In an in vitro mechanism study, B. coagulans demonstrated antagonistic action against a variety of undesirable organisms. B. coagulans supplementation at a dose of 1 billion CFU/day for 28 days GASTROINTESTINAL SUPPORT 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. in adults over age 65 increased fecal concentrations of the commensal F. prausnitzii from baseline compared to placebo; fecal Bacillus spp. also increased in this population. B. coagulans supports GI health.

Coagulans MTCC 5856 given at a dose of 2 billion CFU/day reduced symptoms related to occasional diarrhea in adults with GI disturbance after 90 days of supplementation. Another study found B. coagulans MTCC 5856 was safe when given at the 2 billion CFU dose for 30 days in a group of healthy subjects.6 Symptoms of occasional GI discomfort significantly improved with supplementation of a combination of Bacillus probiotic strains at total dose of 2 billion CFU/day (i.e., B. coagulans SNZ 1969, B. clausii SNZ 1971 and B. subtilis SNZ 1972) for 30 days in 60 adults with occasional GI discomfort.

Bacillus clausii B106
Bacillus clausii supports GI health, a balanced intestinal microbiota, and immune health. B. clausii at a dose of 2 billion CFU twice per day for 10 days has demonstrated significant effectiveness in adults with occasional diarrhea. B. clausii has significantly reduced the duration of occasional diarrhea and decreased stool frequency in a meta-analysis of 1,298 children with dosages ranging from 1 billion CFU twice per day to 4 billion CFU/day. B. clausii has also shown benefit as a probiotic in subjects with small intestinal bacterial overgrowth via normalization of glucose breath test when given at a dose of 2 billion CFU, three times per day for one month in an open-label study.9 B. clausii at an oral dose of 2 billion CFU twice per day was shown to maintain healthy respiratory function after 90 days in a study of 80 participants.

A recent candidate genome analysis performed on the B. clausii B106 strain found genes for several beneficial probiotic properties of the strain (i.e., genes responsible for GI survival and adaptation, adhesion, vitamin synthesis [i.e., riboflavin, folate, biotin], bacteriocins production, stress resistance, etc.). Genes were also present for sporulation, suggesting that B. clausii B106 is a resilient and stable probiotic strain.

Bacillus subtilis (strains HU58 and HS43)
Bacillus subtilis has been shown to relieve GI distress in patients. B. subtilis supplementation of 1-3 billion CFU alongside motility stimulating agents was effective for GI symptom relief at four weeks. Supplementation with B. subtilis HU58 plus B. coagulans SC208 at a total dose of 3 billion CFU/day significantly improved stool consistency and GI symptoms (i.e., occasional abdominal pain, bloating, flatulence) in patients with occasional diarrhea compared to placebo.

Suggested Use:
2 capsules per day or as recommended by your health care professional.

† 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. †