Numerous severe adverse outcomes from Openbiome FMT OpenBiome

[Michael Harrop]

I ask people to post their experiences here, but it seems that most people are too lazy to do so, and perhaps fail to recognize the importance of cataloging experiences publicly and in detail.

There have been a few more that are either deleted now or I forgot where they were.

I'm not linking directly to them because Facebook is a horrible company and platform, the majority of content in those groups is misinformation, and the groups are riddled with scammers & shills for extremely disreputable businesses.

I shared the links with @SFBayFMT5 and he pointed out that they are all women. I said I think it's just a coincidence since the current evidence supports universal donors, does not support donor-matching for sex, and does not show that women experience a greater rate of adverse events. https://humanmicrobiome.info/fmt/

Related:
Analysis of OpenBiome's safety and efficacy (Aug 2018) https://forum.humanmicrobiome.info/threads/analysis-of-openbiomes-safety-and-efficacy-aug-2018.55/

The FDA's "solution" is to impose GMP requirements, and now the stool bank has been "moved" to a GMP lab run by the University of Minnesota, which does not appear to be any better. https://forum.humanmicrobiome.info/threads/fecal-microbiota-transplantation-to-prevent-acute-graft-versus-host-di.834/

Tom ​

Question for people post FMT. I'm 2 yrs 9 months post successful FMT for Cdiff turned septic. This year I have noticed that I have pretty rough seasonal allergies and I've never had them before. Wondering if anyone else has had this happen?

I never met my donor. Per hospital protocol my donor was screened through OpenBiome and shipped directly to the hospital. I was the first patient to have this done in that hospital and it took a lot of hoops and red tape for the Drs to approve it. I had been in ICU for 14 days and this was a last resort. It worked and I'm grateful!! Just curious if other have noticed any of these types of changes

AZ ​

I had 2 fmts for cdiff both donoations from open biome (4/2017 and 5/2017) first failed and I contracted Norwalk virus 2 days post fmt with fever and was hospitalized for 3 days. Repeat fmt a month later with a different donor and severe food intolerances and diagnosed “post infectious IBS”. I’m sure a lot of people like me don’t even link the symptoms to the fmt rather than damage of cdiff itself?

I reported everything and had follow ups for a calendar year. I saw 4 specialist for infectious disease and gastroenterology. They went over potential risks with FMT but I really did not have much of a choice as I was septic and not getting better after 18 months of various antibiotic treatment. Mind you I was pregnant in the beginning as well which added to the timeframe of treatment. Mind you I also have ig deficiencies.

SL 01​

I received an FMT for C diff. I wanted to use a family member...the doctor said it was too expensive and time consuming to go that route and did OPEN BIOME.
My body DOES NOT like the donor....it has changed EVERYTHING...from my sweat to my attitude.
I want an new FMT with a family donor.
Does ANYONE know of a doctor who might help with this? I am not C diff positive anymore...just very very unhappy from the incorrect donor....
Thank you...feel free to PM me.

SL 02
OPEN BIOME gave me methane SIBO. They don’t do lactulose breath tests for hydrogen and methane, thus you don’t know if you will get it from the donor.
I have read FMT research that some doctors are writing that they want SIBO tested with breath tests for this VERY reason.
Methane sibo is very difficult ....I got rid of C diff and got methane SIBO.
I wanted to use a family donor but the doctor said it was too much trouble.
Do it again...I will INSIST. Testing is not that expensive considering all the money and suffering from this SIBO.
Also, people should know that OPEN BIOME does not do the best testing for bad bacteria, parasites, etc...they don’t do the DNA/PCR testing...they just do as much as the FDA makes them ...and that is about 10 years behind the times....I had quite the talk with them.
BTW, DNA/PCR is what we use for child support and to solve crime cases such as rape, food poisoning, parasite infections, etc...isn’t that good enough for us as patients? The fact that lab corp does not do DNA/PCR is why you have to run SEVERAL C diff tests to “catch” it....if you use someone like GI Map, who implements DNA/PCR...it only takes once....open biome is not up to par...Shame on them.
I actually did a DNA/PCR GI Map before and 4 weeks after my FMT.....it was AMAZING what I “caught” from the donor. My doctor WAS actually shocked. A couple of parasites I have NEVER been positive for....fun....
They promised to look into it and NEVER got back to me....they have a captive market...
Also there is research that it is easier on your body to get your own DNA....your child is 50%, etc....less chance of autoimmune and mast cell activation...
Hope this information helps somebody!

The sad thing is that I was tested prior and post FMT. As I said before, I cured my C diff and switched it for methane SIBO which I did not have before. I also “inherited” cryptosporidium, cyclospora, dientamoeba fragilis, E. coli......I am basically homebound, so I did not go out to eat and “catch” SIBO. I finally got past the nurse, who would not take my questions and basically ignored me until I was “escalated” to another level...he is the one that I sent my prior and post DNA/PCR to. He said that he was going to do everything he could to get the donor tested....since they keep a “spare” to test. I emailed him twice and nothing had been done “yet” was his response...I finally gave up and realized I was just being shuffled about. He did say that they could not test as accurately as my tests because of the glycerol content they put into the stool....BUT that they could do more testing on that donor and they would get back to me due to the obvious problem of what showed up in my stool after the FMT....I never heard back. WHAT does that say? I want to know why they could not use some fresh stool from the donor and do DNA/PCR on that sample? I asked the man that and he said that it was not their “protocol”....well, maybe they should not be the only game in town and their protocol should update and change in the case of an emergency of spreading disease

MH ​

I agree with all above. I am 7 mos post FMT #2 was told I could eat anything just increase fiber. Well...that didn’t go well. I finally had food allergy tests and was shocked with what I could eat before but not anymore (esp. no dairy, wheat, yeast)My diet now consists primarily of protein (wild salmon, turkey, chicken, and beef) organic preferred and veggies with very little sugar. Besides my gut feeling better, my sinuses and skin are clear as well. Time is the biggest thing for stomach healing, this is my second round with multiple cdiff so I know it might take even longer before I can slowly introduce more foods. Glad I am not alone, even though I wish none of us had to deal with this.

So the hospital provided the stool and you don't know who the donor was? Could you check with the doctor/hospital whether OpenBiome provided the stool?

Click to shrink...

yes I think that was the company. My memory is fuzzy from that time due to the fact that I was so sick/septic.

ST ​

Thank you for accepting my request to the group. Looking to connect with individuals who have also experienced a fecal transplant due to recurrent, antibiotic resistant Cdiff (ironically caused by antibiotics usage).
March 2018 - cdiff diagnosed
June 2018 - urgent fecal transplant with anonymous donor through Open Biome
Saved my life.
However, no one follows you after the transplant is complete. FDA approved only for emergency cases yet…they don’t want to see what happens to the patient even if not just for study purposes? Bizarre.
I’ve gained 40+ lbs since 2018 and am now prediabetic. Nearly impossible to lose the weight and was never, ever an issue in my past. Additionally, I now suffer from bouts of hydranitis superrativa. Again, never something I ever worried about before.
Thankful to be alive, just wish there was more research/follow up care!
Anyone experience anything similar?

ND 01 ​

I had a colonoscopy based FMT for Cdiff in 2019. Cdiff is gone, still have lymphocytic colitis, but under control. Stool was from openbiome.org. I'm gaining weight uncontrollably. I've never had a weight problem. I'm up 50 lbs. Can this be a trait from the donor? No type of Dr can figure this out.

ND 02
For any of you who have inquired about my huge weight gain saga since colonoscopy based FMT using Openbiome material for Cdiff, they answered me (somewhat) today via email. I asked if obesity is a criteria they screen for and explained my situation. They told me yes, BMI of 29 is upper limit they will accept. I almost went through the roof as my BMI has gone from 21 to 29 (I developed LC from Cdiff, but didn't mention to them, not their fault on the LC). 29 is borderline obese by cardiologist standards, allows for Ozempic or similar by endocrinologist standards, and puts me in high risk category for diabetes. I calmly responded that due to the facts above, and I'm now on statins, 25 should be upper limit. However they haven't traced me back to donor (which I've asked in my reply), once I know BMI of donor, I'll go from there. Guessing donor had high BMI since I never had a weight problem before. Not sure what to do if I'm told donor had BMI of 29. They helped me greatly by finally eliminating Cdiff, but now I have heart disease, my spinal stenosis is worse, and just the psychological aspects of 50 lbs I can't get off (eat once a day, go to gym, have LC) is taking a toll on me. Comments welcome!