October 16, 2023

Published Studies

Spore Studies

Form/Duration	Study Details and Results	Reference
Bacillus subtilis (HU58™) 4 weeks	Daily treatment with oral Bacillus subtilis HU58™ for 4 weeks was safe and well-tolerated in study subjects. HU58™ supported healthy blood ammonia levels.	DOI: 10.1155/2020/1463108
Bacillus subtilis (HU58™) 15 days	HU58™ reduced stool from 7-8 stools per day to 1-2 stools per day. Significant improvement was observed in 16 study subjects (scale 4), mild improvement observed in 6 study subjects (scale 5) and no improvement was observed in 8 study subjects (scale 6). HU58™ was safe, well-tolerated and effective in study subjects.	The Indian Practitioner, 73(4), 22-28.
Bacillus subtilis (HU58™) 8 weeks	Supplementation with 2 billion CFUs of Bacillus subtilis HU58™ was shown to support immune function and is well tolerated and safe for consumption in humans.	The Indian Practitioner, 70(9), 15-20.
MegaDuo™ (RestorFlora™) 2 weeks	MegaDuo™ was shown to support intestinal epithelial barrier function and immune function.DOI:	DOI:10.3390/microorganisms8071028
MegaDuo™ (RestorFlora™) and PreticX® Xylooligosaccharide (MegaPre™) 90 days	MegaDuo™ (RestorFlora™) and PreticX® Xylooligosaccharide (MegaPre™) were shown to support the body’s metabolic processes thereby promoting general health and wellbeing.	DOI: 10.1186/s12263-022-00718-7

Total Gut Restoration Studies

Form/Duration	Study Details and Results	Reference
Total Gut Restoration in vitro (M-SHIME®)	Fecal samples were used in vitro to evaluate the effects on the gut microbiome using the Total Gut Restoration supplementation system. TGR supplementation resulted in short-chain fatty acids (SCFAs) production and supported intestinal barrier function and immune function.	DOI: suppl/10.2217/fmb-2022-0066
MegaSporeBiotic™ and MegaMucosa™	The combination of MegaSpore™ and MegaMucosa™ promoted immune function and provided support to colonic mucosa.	DOI: 10.3390/nu12123607
MegaSporeBiotic™ 10 days	300 million CFU of MegaSporeBiotic™ supplementation supported immune function and iron levels in mice.	DOI:10.1002/jpen.1851
MegaSporeBiotic™ 12 weeks	12 weeks of supplementation with MegaSporeBiotic™ supported triglyceride levels in study subjects.	PMID: 33041703
MegaSporeBiotic™	Administration of MegaSporeBiotic™ was shown to support liver function.	DOI: 10.3390/nu12030632
MegaSporeBiotic™ 60 days	MegaSporeBiotic™ provided relief for occasional abdominal discomfort and supported elimination and digestive health in study subjects.	DOI: 10.3390/nu11091968
MegaSporeBiotic™ 30 days	MegaSporeBiotic™ demonstrated cardiac-supportive and immune-supportive properties.	DOI:10.4291/wjgp.v8.i3.117
MegaSporeBiotic™ and MegaPre™	MegaSporeBiotic™ and MegaPre™ promoted microbial diversity in the transverse and descending colon. Additionally, this synbiotic combination promoted the production of all SCFAs in the gut, including acetate, propionate, and butyrate.	DOI:10.1016/j.ijpx.2019.100021
MegaSporeBiotic™ 3 weeks	MegaSporeBiotic™ promoted bacterial diversity and supported ammonia, propionate, and lactate levels.	DOI:10.1016/j.foodres.2021.110676
MegaSporeBiotic™ and antibiotics	MegaSporeBiotic™ was shown to support immune system health and help maintain normal intestinal flora.	DOI:10.3390/microorganisms10061178

Metabolic Support Studies

Form/Duration	Study Details & Results	Reference
MyoMax™ 8 Weeks	Randomized, double-blind, placebo-controlled trial. 26 participants. Supplementation with MyoMax™ was associated with a 12% increase in maximal cardiac output in aerobically trained athletes.	PMID: 28646812
MenaquinGold® Natural MK (MyoMax™, MegaQuinD3™, MegaQuinone™) 7/ 12 Weeks	Randomized, double-blind, placebo-controlled trial. 42 participants. 180 -360 mcg of vitamin K2 (MK-7) was shown to support bone health.	DOI:10.1017/S0007114511007185
MenaquinGold® Natural MK (MyoMax™, MegaQuinD3™, MegaQuinone™) 7/ 8 Weeks	Randomized, double-blind, placebo-controlled study. 60 participants. Vitamin K2 (MK-7) was well tolerated and displayed to support nerve function health.	The Ind. Pract. 2010; 63(5):287-291
MenaquinGold® Natural MK (MyoMax™, MegaQuinD3™, MegaQuinone™) 3 months	Open-labelled ambulant trial. 19 participants. MenaquinGold® Natural MK (MyoMax™, MegaQuinD3™, MegaQuinone™) was well tolerated and safe with a relief of occasional muscle cramps.	The Ind. Pract. 2010; 63(5):287-291
MenaquinGold® Natural MK (MyoMax™, MegaQuinD3™, MegaQuinone™)	In vitro. MK-7 is able to support immune function	DOI: 10.1089/jmf.2016.0030
MenaquinGold® Natural MK (MyoMax™, MegaQuinD3™, MegaQuinone™) 7/ 8 weeks	Open-labeled observational study. 100 participants. Vitamin MK-7 was well tolerated and displayed to support nerve function health.	DOI: 10.4103/jpp.JPP_72_18

Pet Health Studies

Form/Duration	Study Details and Results	Reference
FidoSpore™ 30 days	Spore-based probiotics support digestive health in dogs.	DOI: 10.3390/ani11051367

Skin Support Studies

Form/Duration	Study Details and Results	Reference
MegaSporeBiotic™ 8 weeks	Single-blinded, 25 participants. Probiotic supplementation helped retain moisture in skin. Probiotic supplementation supports skin health in those with skin issues & improved complexion for those with skin issues. Placebo for the first 4 weeks, followed by 4 weeks of probiotic supplementation.	DOI:10.3390/jcm12030895

Immune Support Studies

Form/Duration	Study Details and Results	Reference
Pylopass® (PyloGuard™) 28 days and 56 days	Placebo-controlled trial 103 participants, children 9-17 years Supported ammonia levels in Pylopass® (PyloGuard™) group Pylopass® (PyloGuard™) group reported higher rate of abdominal relief and reduced incidence of diarrhea	DOI: 10.15406/ghoa.2020.11.00407
Pylopass® (PyloGuard™) 2 weeks	Pilot study 27 participants DSM17648 co-aggregates with human strain of H. pylori without aggregating with any other commensal bacteria.Supplementation supported levels of H. pylori.	DOI: 10.1007/s12602-014-9181-3
Pylopass® (PyloGuard™) 4 weeks	Placebo-controlled, single-blind study 24 participants Supported H.pylori levels and improvement of abdominal discomfort	DOI: 10.1186/s40795-018-0257-4
Pylopass® (PyloGuard™) 4 weeks	Clinical study 30 participants Supported H. pylori levels Positive dynamics of occasional GI issues	DOI: 10.1016/j.imr.2014.04.001
Pylopass® (PyloGuard™) 2 weeks	Placebo controlled study 22 participants Supported H. pylori levels Effect still observed 6 months after end of supplementation	DOI: 10.3390/nu5083062
Pylopass® (PyloGuard™) 4 weeks	Randomized, double blind, placebo-controlled clinical study 200 participants Significant improvement of side effects compared to placebo group Promoted abundance of Fusicatenibacter, Subdoligranulum, and Faecalibacterium Mean GSRS score decreased significantly in the LR group as compared with the placebo group	DOI: 10.1111/hel.12856
Pylopass® (PyloGuard™) 2 weeks	90 participants Prospective and interventional randomized, double-center study. 86% eradication rate in Pylopass® (PyloGuard™) group. 20% higher eradication rate compared to standard therapy group. Significant reduction in symptoms compared to standard therapy group.	DOI: 10.9734/jpri/2021/v33i52B33611
Mega IgG2000 2 weeks	In a randomized, double-blind, placebo-controlled, pilot study evaluating SBI in children 8-18 y with d-IBS, we collected stool number, abdominal pain, and stool type for 1 wk. We assigned patients at a ratio of 2:1 to SBI 5 gm BID or placebo for 3 wk. Patients and parents completed Pediatric Quality of Life Inventory for Gastrointestinal Symptoms (PedsQOL), the Pediatric Functional Disability Index (FDI), complete blood counts and serum chemistries at the start and end of treatment. Fifteen patients (9 SBI, 6 placebo) completed the study. Both groups reported reductions in stools/wk and abdominal pain, and improved stool form. There was a trend for fewer stools in the SBI group compared to placebo. FDI and PedsQOL scores improved. in the SBI group, but not placebo. No serious adverse events occurred. SBI was safe in children with d-IBS, with improvement in symptoms.	DOI: 10.2147/PHMT.S159925
Mega IgG2000 duration and dose unspecified	*White Paper- Summary* Immunoglobulins in SBI have been shown to bind to a variety of conserved microbial antigens that are associated with immune activation (e.g. LPS, flagellin). Commensal-specific immunoglobulins (e.g. IgG, IgM, IgA) occur naturally in both plasma and the gastrointestinal tract. Preclinical studies demonstrate that SBI does not adversely affect the growth of commensal & probiotic bacteria in vitro or cause changes in the intestinal microbiota in an animal model used to evaluate host-microbiota relationships. Data from human studies indicate no significant changes in commensal microflora following oral administration of EnteraGam. Commensal-specific immunoglobulins likely provide a health benefit by supporting gut homeostasis and immune regulation activation.	Proliant Health (2016). EnteraGam: Managing Gastrointestinal Conditions While Not Harming Beneficial Bacteria [White Paper]
Mega IgG2000	Serum‐derived bovine immunoglobulin (SBI) is a protein isolate rich in immunoglobulins for oral administration to improve immune health. SBI reduces inflammation by binding and neutralizing a variety of inflammatory antigens, improving gut epithelial barrier integrity, and maintaining gut homeostasis. In this study, fluorescence spectroscopy was used to demonstrate and quantify the binding of SBI to the fungal mycotoxins, aflatoxin G1 (AFG1) and aflatoxin B2 (AFB2). Calculated binding constants reveal SBI binds with both AFG1 and AFB2 in a dose dependent manner, likely through immunoglobulin‐aflatoxin interactions.	Proliant Health (2023). Mycotoxin Binding to SBI and Bovine Immunoglobulins [White Paper]
Mega IgG2000 5g, ex-vivo study	When dosed at an equivalent of 5 g/day, all protein fractions significantly increased health-related metabolites—acetate, propionate, and butyrate. Upon simulating small intestinal absorption, SBI still markedly increased acetate and propionate, demonstrating that SBI is more resistant to small intestinal digestion and absorption compared to the other protein sources.	DOI: 10.3390/microorganisms11030659

Cognitive Support Studies

Form/Duration	Study Details and Results	Reference
*Bifidobacterium longum* 1714® (Zenbiome Cope™ & Sleep™) 4 weeks	Placebo-controlled study. 22 participants. 1714® strain supported cortisol levels and reduced perceived stress levels throughout the study compared to the placebo group. Significantly lower perceived stress levels in those participants taking B. longum 1714® compared to the placebo group. Bifidobacterium longum 1714® (Zenbiome Cope™ & Sleep™)	DOI: 10.1038/tp.2016.191
*Bifidobacterium longum* 1714® (Zenbiome Cope™ & Sleep™) 4 weeks	Randomized, double-blinded, placebo-controlled trial. 40 participants. 1714® strain supported relaxation reduced stress, and enhanced mood Difference of neural activity change during resting state in theta band after 1714®- promoted theta brainwave activity at rest, compared to the placebo group. Difference of neural activity change during resting state in beta 2 band after 1714® supported body’s adaptation to beta 2 brain wave activity at rest, compared to the placebo group.	DOI: 10.14309/ajg.0000000000000203
*Bifidobacterium longum* 1714® (Zenbiome Cope™ & Sleep™) 4 weeks	Double-blind, randomized, placebo-controlled, repeated measures, cross-over design. 20 participants. Overall sleep quality and duration of sleep improved significantly in the probiotic treated group during exam stress compared with the placebo treated group.	DOI: 10.1016/j.bbih.2020.100174
Bifidobacterium longum 1714® and Bifidobacterium longum 35624® (Zenbiome Cope™ & Sleep™) 8 weeks	Open label exploratory study. 40 participants. This exploratory open-label study found that 82% of subjects had significantly improved issues after 8 weeks, with 66% of subjects significantly improving after 4-weeks (issue severity score change of ≥ 50) in the moderate to severe group. The combination solution improved each of the individual issues (occasional abdominal discomfort, distension, bowel satisfaction), as well as an improvement in their quality of life. Participants in this group also had a significant improvement in their morning cortisol awakening response, a physiological biomarker of stress, after 4-weeks.	DOI: 10.1111/nmo.14477

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