Science | Gnubiotics

The Science

AMObiome Product Efficacy, Safety and Clinical Validation

AMObiome has undergone six well-controlled clinical trials involving over 200 companion animals (cats and dogs), demonstrating:

Consistent efficacy in improving microbiome composition (increase in beneficial microbes, decrease in pathogenic species)
Excellent safety and tolerability
Significantly preferred palatability with improved food consumption and food preference scores

Additionally, extensive in vitro studies have confirmed AMObiome’s mechanism of action of growing beneficial microbes and inhibiting pathogens.

Clinical Trials Overview: AMObiome has been evaluated in a series of rigorous clinical studies designed to assess safety, tolerability, efficacy, and palatability in both cats and dogs. These trials meet the standards required for regulatory submissions and commercial claims, including the U.S. FDA’s GRAS (Generally Recognized as Safe) notification process.

Key trial highlights

6-Month FDA GRAS Safety Study – Cats & Dogs.

Conducted in compliance with FDA guidance.
Demonstrated long-term improvement of the microbiome, safety, excellent tolerability, and no adverse events.
Supported AMObiome’s FDA GRAS status.

Antibiotic Challenge Recovery Study – Dogs

Evaluated microbiome recovery following antibiotic-induced microbiome dysbiosis.
AMObiome significantly accelerated the restoration of microbiome diversity.
Reduction in pathogenic count (E. coli and Streptococcus) and restoration of beneficial microbial populations.

Palatability and Preference Trials – Cats & Dogs

AMObiome improved food acceptance and consumption in standard and premium diets.
Particularly effective in picky eaters and animals under stress.

Other Trials

Digestive performance assessments.
Assessments in puppies.
Immune biomarker studies.

Mechanism of Action

In vitro studies: Numerous in vitro studies demonstrate how AMObiome works and why it is superior to current prebiotics. AMObiome’s unique and multiple oligosaccharide structures bypass the upper GI digestive tract and enter the lower GI intestine tract, where the vast majority of the gut microbiome resides. There, it selectively feeds and promotes the growth of beneficial microbes, such as Lactobacillus, Bifidobacterium, and Faecalibacterium. Simultaneously, AMObiome inhibits the growth of harmful pathogens, such as Clostridium perfringens and Escherichia coli, and other enteric pathogens.

Additionally, beneficial microbes produce essential metabolites, such as short-chain fatty acids (SCFAs), known to improve gut lining integrity and enhance the immune response.

See Applications

Publications:

Effect of a novel animal milk oligosaccharide biosimilar on the gut microbial communities and metabolites of in vitro incubations using feline and canine fecal inocula

Effects of a milk oligosaccharide biosimilar on fecal characteristics, microbiota, and bile acid, calprotectin, and immunoglobulin concentrations of healthy adult dogs treated with metronidazole

Effect of a novel animal milk oligosaccharide biosimilar on macronutrient digestibility and gastrointestinal tolerance, fecal metabolites, and fecal microbiota of healthy adult cats

Evaluation of a novel animal milk oligosaccharide biosimilar: macronutrient digestibility and gastrointestinal tolerance, fecal metabolites, and fecal microbiota of healthy adult dogs and in vitro genotoxicity assays

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