Ethics concerns about a Finnish FMT clinical trial giving infants FMT from their mothers. "Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study (MT-SECFLOR)", Helsinki University Central Hospital. (Nov 2019)

I sent this letter 3 weeks ago, both to the researchers and the ethics bodies and individuals listed on their hospital's website. I received no response from any of them.

Hello,

I just saw your FMT clinical trial https://clinicaltrials.gov/ct2/show/NCT04173208. I found a few concerning/shocking things about the listing, and also wanted to pass on some information about donor quality.

The first thing that concerned me is FMT to a child from a mother. I understand that the normal birthing process is messy and fecal microbiota can get transferred in this way. However, I think that the current literature raises many concerns about purposely doing full FMTs from an adult to a child/infant:

https://humanmicrobiome.info/aging/

https://humanmicrobiome.info/fmt-questionnaire/

The second thing I found surprising is that you're using mothers who chose to have elective c-sections. I am shocked that elective c-sections are allowed in Finland, particularly due to the fact that the Nordic countries seem to have some of the lowest c-section rates in the world. If you're not sure why I'm shocked see:

• https://humanmicrobiome.info/maternity/
• https://forum.humanmicrobiome.info/threads/while-antibiotic-resistance-gets-all-the-attention-the-damage-being-do.50/
• https://www.mdedge.com/ccjm/article/189671/infectious-diseases/our-missing-microbes-short-term-antibiotic-courses-have-long

Regarding donor quality, I believe donor quality is currently the most major flaw of FMT studies. Current standards for FMT donors are completely inadequate for both safety and efficacy, thus resulting in a massive waste of time and money, and putting patients at risk and delaying effective treatment: https://forum.humanmicrobiome.info/threads/another-letter-to-the-nih-and-fda-cancer-patients-as-fmt-donors-if-you.59/

Given how hard it is to find high quality donors, it seems vastly less likely that you'd be able to find high quality donors among mothers electing to have a c-section. Additionally, your inclusion criteria do not mention anything about the mother's/donor's health. Thus, it appears that your donor quality will be much worse than the already abysmal standards, which seems incredibly unethical and irresponsible.

The above and below links provide additional information. 

To me, the obvious ethical alternative would be to screen young children/toddlers/infants to be FMT donors, and use the ones who qualify as donors for c-section infants. The child-donor's parents would need to be screened as well, since it's difficult to gauge the health of people that young.

But that requires significantly more effort. So, like the FMT clinical trials using cancer patients as donors, they don't bother putting in the extra effort to find safe and effective donors.

It is quite frustrating to not only see so much incompetence and laziness among the medical and research communities, but it's additionally frustrating to see the lack of responsive/effective regulatory/oversight/policing/ mechanisms/entities.

I think this highlights the importance of projects like pubpeer.com. And anyone who allows themselves to be influenced by any study should have the pubpeer browser addon https://pubpeer.org/static/extensions installed.