Download "Consent to Participate in Research"
Introduction
You are invited to participate in a research study conducted at the University of Calgary by Dr. Davide Martino, and associates from the Department of Clinical Neurosciences.
This consent form is only part of the process of informed consent. It should give you a clear idea of what the research is about and what your participation will involve. If you would like more detail about something described in this consent form, or information not included in this document, please do not hesitate to ask. Take the time to read this consent form carefully and to understand any accompanying information. You will receive a copy of this form for your records.
You were identified as a possible participant in this study because you have Parkinson’s Disease.
Your participation in this research study is voluntary.
Background
The microbiome is the collection of all microorganisms (such as bacteria, fungi/yeast, and viruses) that naturally live on our bodies (e.g. skin) and in our bodies (e.g. mouth, airways, small intestines and large intestines).
It is known that the small intestine (or bowel) may hold information that is of great importance in understanding human health though it has remained, to this day, relatively unexplored, because the access is difficult. A better understanding of the small intestine microbiome may help drive the search for new insights in Parkinson’s disease or its treatment.
Treatment of Parkinson’s disease with oral L-dopa may have limited efficacy in a proportion of patients with this condition. In particular, patients may report a fluctuation in the effect of this medication throughout the day, as well as that the effect of some doses may fail to ‘kick in’. A possible reason for this is that the small intestine, where L-dopa is absorbed and enters the bloodstream through which it ultimately reaches the brain, may host specific microbes that digest L-dopa and therefore reduce its absorption. This mechanism could not be easily explored to date because collecting small intestine fluid would require endoscopy, which is costly and invasive.
The SIMBA Capsule (designed by Nimble Science Ltd.) potentially offers a simple and easy alternative to obtain a sample of the small intestine microbiome, suitable for analysis. The SIMBA capsule measures about 25x9mm at the time of ingestion (when it is swallowed), which is similar to commonly self-administered capsules of food supplements such as fish-oil.
When swallowed, the capsule will pass through the stomach into the small intestine where it is expected to collect a sample of the fluid content from the small intestine. This sample may be used for basic research (to discover something), clinical research (to research if a given treatment is effective) or for diagnostic evaluation (to confirm or disqualify a known disease).
The SIMBA capsule consists of a small pill sized container within a specially coated shell. This coated shell is designed to resist to the acidic stomach environment and to dissolve in the small intestine. Once the shell is dissolved, the capsule can collect a fluid sample from the small intestine through the specially designed openings that are now exposed. At the same time, the fluid in the small intestine softens a latch on a spring-loaded plunger that forms part of the capsule. This leads to the plunger closing the openings and sealing the sampled fluid contents within the container. The sealed container can then be collected by the patient or caregiver with a subsequent bowel movement and returned to the laboratory for analysis.