About the Technology
In vitro simulation technologies
Well-designed in vitro simulation technologies are a complementary tool to human and animal studies. Being representative for specific processes, such models enable reproducible detailed studies of these processes without ethical constraints.
In vivo animal studies
ProDigest can perform in vivo animal studies to validate in vitro results, using conventional or germ-free/gnotobiotic and Human Microflora Associated (HMA) rodents.
In vitro simulation
Well-designed in vitro simulation technologies offer a very useful complementary approach for human or animal studies. Being representative for specific processes, such models enable reproducible in-depth studies of these processes without ethical constraints. The easier setup and sampling allow medium to high-throughput studies at lower costs and offer the unique capacity to evaluate the mechanism of action of a specific compound. For this reason, ProDigest based its activities on the validated in vitro SHIME® technology platform, which is internationally accepted as a representative simulation of the gastrointestinal tract.
The SHIME® technology is combined with a broad array of complementary model systems and analysis techniques, making ProDigest an essential tool for innovative product development. A crucial factor, which determines the relevance of using this extensive in vitro approach, is the question into what extent the obtained data may be translated to the human situation. All our models have therefore been extensively validated with animal and human studies.
In vivo animal
ProDigest can perform in vivo animal studies to validate in vitro results - using conventional or germ-free and Human Microflora Associated (HMA) rodents - and other animal models (i.e. chickens, pigs...).
HMA rodents are germfree animals inoculated with specific or complex human intestinal bacterial communities, allowing to specifically transfer certain components of the human flora into the animal GI tract. HMA animals represent an efficient model to study the ecology of intestinal flora and bacterium-host interactions in a standardized model of the human gut, by excluding difficulties in controlling genetics, environmental and dietary conditions which occur when performing human intervention studies.
The in vivo rodent model allows to integrate physiological host factors in the study and can act as a validation of previous in vitro findings related to the bioavailability and generation of active compounds in the GI tract, the evaluation of pre-, pro-, or synbiotic treatments and the interaction of the microbial ecosystem with the host.
Chickens, pigs and other specific animals can be used to assess the effect of ingredients/molecules specifically developed for a given animal model. Pigs are also frequently used as a proxy for the human gastrointestinal tract.
As a final validation of previous findings based on its technology platform ProDigest human intervention trials in collaboration with medical institutes.
The combination of the ProDigest's in vitro technology with human intervention studies is the ideal strategy to design and perform the latter studies under optimal and cost-effective conditions.
Application of the technology platform allows to unravel and identify many of the crucial factors which determine the success of a human intervention study. This includes among others the elucidation of specific metabolic processes and possible interindividual variability, screening and selection of the most promising product lead and optimization of the best formulation strategy (e.g. encapsulation, slow-release strategies ...).
Availability of these in vitro data allows to organize a human study with the most promising product and optimal formulation, thereby increasing the study's chance of success. In addition, understanding the metabolic fate and interindividual variability allows to better select the target population, further increasing the quality and the power of the study. All these aspects lead to a cost-effective and high quality proof-of-concept study which provides all necessary information to support the functionality of a given compound.
Typical examples of ProDigest's experience related to this integrated strategy are the evaluation of pro- and prebiotics and the bioavailability of active compounds generated by variable intestinal microbial metabolism (e.g. plant polyphenolics) in a randomized, double-blind, placebo-controlled design.