Author: Solana Pinilla – 08/04/2024
Did you know that your intestinal microbiota could save lives?
Stool donation is a novel practice that contributes to the development of modern medicine that seeks effective therapeutic alternatives to various serious, chronic and massive pathologies.
Although it is a new process about which little is known, it is a highly regulated procedure according to the regulations in force in each country. There are several stool donor banks in the world, the pioneer in the United States was “OpenBiome”, and the first in Spain is Mikrobiomik, at a private level. Surely, over time, more information will be communicated and provided on the subject, so that being a stool donor becomes an act as normalized as being a blood donor is today.
Regulations for stool donation
With all the talk about donor compensations, it’s essential to clear up some points. In Spain, we follow Law 14/2007 on Biomedical Research, especially article 58. This article covers getting biological samples for research and states that donors need to give written consent and be informed about any health risks. The Spanish Agency for Medicines and Health Products (AEMPS) oversees the quality and safety of medicines in Spain. They also supervise clinical trials and new therapies like fecal microbiota transplants (FMT), giving rules for stool donation and use.
In the United States, the responsible authority is the Food and Drug Administration (FDA), which oversees the donation of stool for medical reasons, like fecal microbiota transplants (FMT).
Compensation for being a stool donor
We know that one of the most frequently asked questions is: Is the donor paid? And we can technically answer yes, but it is not correct to speak of a “payment”, but rather of financial compensation. According to the aforementioned law 14/2007 in Spain, it is established that “financial compensation may be set for physical discomfort, expenses and other inconveniences that may arise from taking the sample.”
The amount may therefore vary depending on the effort required by the person to go to the site designated for the collection of the sample, as well as other transfers and the time required for the prior process of interviews and analyses. Compensation is given for each valid donation made by the person, and up to 4 donations can be made per week within a period of up to 2 months. In no case will this compensation be equivalent to a salary, but rather it is considered as a “bonus” or extra that will be received by the donor who voluntarily agrees to collaborate with medical research for the development of new therapeutic alternatives.
In the US, the FDA does not prohibit financial compensation, stool banks and research centers can compensate donors, however, the exact details and practices of compensation can vary between stool banks and are subject to ethical guidelines and state regulations. Following the same approach as Spain, compensation is intended to cover the inconvenience and time invested by donors, and not to act as an excessive and unjustified incentive. This is followed by OpenBiome, the world’s first stool bank, founded in Massachusetts in 2012, a company that leads the recruitment of stool donors and has managed to generate interest globally.
Why should I be a donor?
Using donated stool and an innovative technological process, the microbiota is isolated and purified, finally transforming it into a 250 mg capsule of freeze-dried intestinal microbiota.
Thanks to the efforts of donors, this biological drug is obtained under investigation and is administered in different clinical trials to patients who do not have an effective therapeutic alternative and who are suffering from various pathologies that threaten their health. The field of microbiota is relatively new and its research is growing. We know the potential of this ecosystem of microorganisms that resides in our digestive system, although there is still much to discover. For this reason, contributing with your donation to continue researching in this field is very encouraging and could lead to important advances in medicine to improve the quality of life of thousands of people.
We refer to the ICD-01 clinical trial, already concluded, for patients infected with Clostridioides Difficile, a bacteria that causes severe diarrhea, and generally affects older people with multiple pathologies. We thank the 41 people who have approached Mikrobiomik and participated anonymously as stool donors. They are our silent heroes, since without their “contribution” this study would not have been possible. We are aware that something as simple as a stool donation can save many lives.