The Fecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus (FACT-T1D) trial is testing a new approach to treating or curing type 1 diabetes. This method involves the use of encapsulated, freeze-dried, autologous (one's own) fecal matter. The idea is that by altering the gut microbiota, it might be possible to slow down or even halt the destruction of beta cells, which are crucial for insulin production.
I've previously blogged on similar research here: https://cureresearch4type1diabetes.blogspot.com/2020/12/results-from-faecal-microbiota.html
The researchers believe that this treatment could help because they think gut microbiota plays a significant role in type 1 diabetes.
Previous studies, including those mentioned in my blog, have shown that fecal microbiota transplantation (FMT) can alter the microbiota composition without serious side effects. In an earlier study, ENCAPSULATE, done by the same researchers, it was found that multiple infusions of one's own feces preserved residual beta cell function up to one year after the start of the FMT. This suggests that encapsulated autologous FMT could be a safe and feasible option for prolonged treatment. This new, larger clinical trial is designed to confirm those promising early findings.
The treatment involves ingesting capsules containing the freeze-dried fecal matter daily for six months. This method has been used in the past and is considered safe.
The Study
The FACT-T1D trial is a double-blind, placebo-controlled study, meaning that neither the participants nor the researchers know who is receiving the actual treatment (2/3s of the people) or the placebo (1/3 of the people). The trial aims to enroll 110 participants who are recently diagnosed with type 1 diabetes (within 100 days of diagnosis), aged 18 to 45. Participants in the trial will take these special capsules daily for six months.
The primary endpoint of the trial is to measure C-peptide, which is the standard way to measure how much insulin the body can produce. Secondary endpoints include other measures of C-peptide levels, HbA1c levels, glucose time-in-range, and insulin dosing.
The trial is funded by the Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) and is being conducted in collaboration with Diabeter Centrum Amsterdam. For more information or to inquire about participation:
Contact: Nordin MJ Hanssen, MD PhD Phone: 020 566 9111 Email: n.m.j.hanssen@amsterdamumc.nl.
Backup: Max Nieuwdorp, MD PhD. Phone: 020 566 9111
They hope to finish in September 2029. Recruiting 110 people at 1 location takes a while.
Discussion
Fecal Transplantation has been used for over a decade to treat a recurrent gut infection caused by C. difficile. It has a strong safety record when using screened donor material. However, autologous FMT (using a patient’s own stool) is considered even safer because it eliminates the risk of transmitting unknown pathogens.
These researchers have been studying the microbiome’s role in metabolism and autoimmunity for over a decade. Their earlier work included the ENCAPSULATE pilot study, which provided the foundation for this larger trial:
This earlier study enrolled 10 people who had T1D for between 1/2 and 3 1/2 years, and followed them for 3 months before giving them FMT and then 3 months while they took it, and 3 more months afterwards. Average C-peptide numbers dropped a little during the first 3 months (predosing) but stayed constant during the next 6 months, and the researchers consider this a success motivating this following study.
I'm not excited about these results. During the honeymoon phase, some researchers do assume that loosing C-peptide production is normal, so holding steady is a success, but I've been watching these studies for years, and I don't think that is enough. I want to see C-peptide production increase, not just hold steady. Furthermore, this study enrolled both honeymooners and established T1Ds, and holding steady is exactly what an established T1D is expected to do. So I'm not optimistic.
However, one of my cardinal rules of watching research, is that once a study has started, none of my doubts matter. There is no reason not to see how it ends. So I will wait for the results, and hope for the best.
Gut bacteria, and fecal transplantation to change gut bacteria, are trendy research areas, and there are several other studies underway now:
- https://www.clinicaltrials.gov/study/NCT05622123 Ongoing.
- https://www.clinicaltrials.gov/study/NCT06496412 Ongoing.
- https://www.clinicaltrials.gov/study/NCT04124211 No results published.
- https://www.clinicaltrials.gov/study/NCT04749030 This was targeted at people with T1D who also had stomach problems. The treatment did reduce stomach problems and did not have adverse effects, but no changes to T1D were reported (A1c was a secondary output, but not reported).
Reminder: this blog covers treatments being tested on people aimed at curing, preventing or delaying T1D, even if they are gross. 😝
More Information
For more information about the FACT-T1D trial, you can visit the following resources:
- FDA's Clinical Trials registry: https://clinicaltrials.gov/study/NCT07083882
- Wikipedia: https://en.wikipedia.org/wiki/Fecal_microbiota_transplantation
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official BreakthroughT1D or JDCA news, views, policies or opinions. I sometimes use generative AI ("chatbots") to generate draft blogs, parts of blogs, or drafter alternate wordings for these blogs. I always review every part of every published blog to ensure that it is saying what I want, in the tone that I want, truthfully, and accurately. My kid has type-1 diabetes and has participated in clinical trials, which might be discussed here. I am obese and right on the border of T2D and therefore may be taking drugs for those conditions. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog!
