Lead Investigator: Werner Weitschies, University of Greifswald
Title of Proposal Research: Development and improvement of an in vitro tool, which simulates the physiological characteristics of the ascending colon
Vivli Data Request: 7818
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
The gut microbiome is the collection of microorganisms including bacteria, archaea, viruses, and fungi found within the gut and their overall genetic information. The human gut microbiome has become more and more important in the recent years, including in the field of pharmaceuticals. Colon targeting in particular plays an important role where it is about the targeted release of active metabolites in the large intestine. This includes, for example, the treatment of local diseases such as inflammatory bowel disease or colorectal cancer.
In order to examine the processes of drug metabolism, in vitro (outside the living body and in an artificial environment) models which reflects the physiological conditions of the proximal large intestine are of interest.
As part of our research, we are engaged in the development of an in vitro model that reflects the physiological conditions of the ascending colon. Relevant parameters are for example pH, temperature, redox potential and the human gut microbiome. This model should be improved that it also will be possible to investigate unknown drugs and substances regarding their metabolism in future. However, we have considered that it is useful to conduct series of experiments with drugs that are assumed to be metabolised by the human microbiome in the colon based on existing literature. The planned series of experiments will strictly take place in our in vitro model, so no study with human test persons is planned. Only bacteria obtained from stool samples from human healthy volunteers will be used. Subsequently, the generated data from the series of experiments will be compared and discussed with existing literature and data from other studies.
Requested Studies:
Absence of Excretion of the Active Moiety of Bisacodyl and Sodium Picosulfate into Human Breast Milk: an Open-label, Parallel-group, Multiple-dose Study in Healthy Lactating Women
Data Contributor: Sanofi
Sponsor ID: PubMedID: 21697613