Probiotics for ME/CFS and IBS, Julin et al, Stora Sköndal (Sweden)

Stora Sköndal ME/CFS Center in Stockholm, in collaboration with ImmuneBiotech Medical Sweden (Shahram Lavasani, among others) will be starting a new research project this autumn.

Primary investigators are Dr Per Julin and Dr Anders Rehnström.

The aim of the study is to investigate the effect of probiotics in a group of people with ME/CFS who also have IBS or other GI symptoms. The treatment consists of taking one capsule a day, 5 days a week, for 3 months.

They are planning on recruiting 80 participants. The study will run for 6 months and will be split into two parts, 3 months each. It will be placebo controlled.

Inclusion criteria are having a ME/CFS diagnosis (my guess would be CCC, since that's the diagnostic criteria this centre usually uses), being a patient at Stora Sköndal ME/CFS Center, and having IBS or other GI symptoms.

Exclusion critera are if you're currently on a probiotics treatment (wash out two weeks before the trial starts is ok), if you're currently participating in another ME/CFS treatment trial, or if you have recently started using a new medication/treatment.

The product that is to be tested is called GutMagnific. It contains 5 different probiotic lactic acid bacteria. Its effects are (according to the info sheet sent to potential participants):

* Adjusts imbalances in the intestinal flora by lowering the proportion of "disease assisting" (sorry, can't find a better word atm) bacteria.
* Lessens leaky gut.
* Lessens inflammation in the gut and other organs.

More details on ImmuneBiotech’s info page about the product.

The info sheet says that the risks of treatment with probiotics is generally very small. Sometimes mild discomfort, like for example gas for the first few days.

All the bacterial strains in the capsules are isolated out of traditional cultured food like fermented vegetables and original cultures of yoghurt. The bacteria belong to known strains like Lactobacillus plantarum, Lactobacillus brevis and Lactobacillus salivarius, and are all on EFSA's list of bacteria that are safe for human consumption. All the bacteria are sensitive to the antibiotic Erytromycin, in case a need for treatment against the bacteria should arise.

(I’m not aware of any publicly published info about this study as of yet, except for the ImmuneBiotech page linked above. Please do share if you happen to find anything.)

 

Good news about this study. My understanding though, is the more good strains in a probiotic the better. Seems like just three strains is not very complete. But, maybe there is much more to this story regarding the three strains.

OK, looking at the website for this product, there are 5 strains in all. Still seems like not enough, but I'm not a probiotic, or microbiome expert.

Should be interesting to see the results. I hope other probiotic companies look at ME.

 

Thanks for correcting me Editing my original post!

 

@mango, you're welcome. I thought maybe the 3 strains you noted were just of one type that were more important.

Anyways, hope the study goes well, or is at least illuminating. The momentum for microbiome studies seems to be increasing. IMO that's a hopeful development.

 

Surely they should check beforehand what the people's levels of intestinal bacteria are like at the start. Otherwise the research is kind of meaningless. Some people with ME have SIBO and will be made worse with probiotics.

 

From what I've read about this study, it requires you to attend the clinic twice, once before it starts and one more time later. These meetings are to get information and talk to a nurse. The testing is done on your own at home, it I understood things correctly.

As with so many studies, this means that the homebound patients can't participate. Maybe that's good, if it's because they don't want people who are very ill to attend because it's too risky. However, I do wonder about the choice to not study the most severely ill people. Will the results from this study really contribute to anything if we don't know if the results are valid for the most severely ill? What if they get a positive result, will the homebound people then also get this capsule recommended as a treatment? Will the risks be realistically assessed and communicated?

I realize that I come across as very pessimistic but considering how we already have a problem with study results being claimed to be applicable to groups that were never studied I'm generally very suspicious of studies that don't study the more severely ill patients.

 

Questionnaires, blood tests and fecal samples before and after treatment.

ETA: To clarify, like Clementine wrote, you do the fecal sample part yourself. They give you instructions, a plastic container and a special pre-paid envelope so you can mail the samples in.

I agree with everything else in Clementine's post as well. Not pessimistic, just realistic.

 

@Clementine

Your point about recommendations being made for groups not studied is very important. Thank you for making it. All along there has been so much in the way of "treatments" recommended for pwME when we haven't been studied. A big example are the Oxford criteria studies making recommendations about pwME when the subjects studied were a heterogeneous group.

Maya Dusenbery's book Doing Harm: The Truth About How Bad Medicine And Lazy Science Leave Women Dismissed, Misdiagnosed and Sick, emphasizes another aspect of treatment without first studying: for decades women were not included in drug trials.

@Midnattsol

Good point about commercialism and ME. We've already been there and continue to be so with GET and CBT.

 

For those of you not already familiar with Shahram Lavasani. He's an immunologist at Lund University. He has been involved in ME since 2016, and among other things attended the IiME colloquium and conference.

Here's one of Lavasani's previously published papers (MS, used a mouse model):

Lavasani et al (2010) A Novel Probiotic Mixture Exerts a Therapeutic Effect on Experimental Autoimmune Encephalomyelitis Mediated by IL-10 Producing Regulatory T Cells
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0009009

More papers at ResearchGate.

 

Per Julin at Stora Sköndal/Karolinska Institutet is a MD, PhD, specialist in rehabilitation medicine (brain injury focus), with clinical research in cognitive disorders, especially neuroimaging, including 6 years at Astrazeneca R&D, Clinical experience with ME/CFS since 2010.

Publication list:
https://www.ncbi.nlm.nih.gov/pubmed/?term=julin+p

 

Is there any online information about recruitment for the study?

 

Not that I'm aware of. If I had to guess, I'd say that since one of the inclusion critera is that you have to be a patient at Stora Sköndal ME/CFS Center, maybe they will recruit people by contacting their current patients directly? Letters have been sent to some of their patients, that much we know.

 

I'm also wondering about the recruiting process, because they don't seem to contact all of their patients. I'm a patient there and I have IBS but I haven't been asked to participate.

I get home visits from them because I get so very affected when I leave my home (which I do like once a year) and suspect that it could be the reason for not being asked to participate. However, it's just a speculation from me and not something I actually know.

 

It's nice to see trials carried out for something else than CBT/GET/LP/"insert your favourite brainwashing scheme", especially in Europe, where basically zero immunological research trials have been carried out.

I'm skeptical regarding the choice of probiotic, however. Lactic acid bacteria is what you will find in every cheap probiotic mix on the supermarket shelf, mostly because they a) have a good shelf life b) survive the stomach acid well and c) are moderately safe and actually don't colonize the gut, so the effect is transient and stops soon after you stop taking the product. I don't see anything "new" in using yet another fancy-name probiotic with some random combination of popular, commonly available lactic acid bacteria and only five strains of them. It could provide something new if the CFUs were significantly higher than in other products, but I doubt it.

There has been other high quality lactic acid products like VSL#3 available for decades and I know a large number of patients have tried them. We would know by now if such common bacteria would provide significant benefits.

 

I dont think lactic acid bacteria are going to do much, to be honest. In any disease. LAB is readily available because its easy to grow through fermentation of foods. But it's such a tiny slice of the human gut flora, most of our gut is (or should be) made up of other types of bacteria in much larger proportions than LABs.

There was some research a few years ago, in IBD i think, where they managed to produce pills with a properly representative selection of gut flora. Not the kind of thing you can buy over the counter. That's where I'd think research in MECFS would be more worthwhile.

 

@JES

I agree, in taking probiotics for many years, I have noticed the effect is definitely transient.

I find all probiotics are rather costly for such short-lived assistance. Nice work if you can get it!

I've recently switched up to a better mix, and switch to another product periodically.

ME, and those who suffer from this terrible disease are very good to the supplement industry.

ETA: I was interested to note that our dogs' probiotic, I give them when they eat unsavoury things in the wild, has some cross over with brands available for people.

One could say woof to this!

 

GutMagnific on Facebook today (auto translation):
Now we start a clinical study to investigate the effect of GutMagnific ® at ME / CFS (myalgic encephalomyelitis / chronic fatigue syndrome) in collaboration with Stora Sköndal's ME / CFS clinic.

During the current Coronapandemic, we carry out the study remotely. Participants themselves have to estimate their symptoms through different self-estimate forms and take samples sent for analysis.

The study is particularly important right now because it is feared that COVID-19 will increase the number of ME / CFS cases. It has been seen in the past that ME / CFS often arises as a persistent flu-like inconvenience so-called post-viral fatigue after a severe infection.

GutMagnific has a website in English and Swedish where they sell their product:
https://www.gutmagnific.com/en

 

More information from 17th Jan 2020 from CORDIS (The Community and Research and Development Information Service), the European Commission's primary source of results from the projects funded by the EU's framework programmes for research and innovation.

Evidence-based probiotic for Chronic Fatigue Syndrome

GutMagnific™ is an evidence-based probiotic scientifically designed and shown to be effective in correcting the gut microflora disbalance – a source of CFS and IBS symptoms. The novelty of the product lies in the unique combination of 5 lactobacilli strains with evidence-based efficacy and shows a life-changing promise to severely underserved population of CFS patients.

...

Since 35-90 % of ME patients also suffer from IBS, the hypothesis of the upcoming clinical trial is that if IBS can be ameliorated by GutMagnific®, then the ME symptoms could also be improved. “With GutMagnific® we are conceiving a new probiotic category of products designed with pharmaceutical precision, where the starting point is the specific condition, not the probiotic strain!” says Karin Larsson ImmuneBiotech Chief Business Officer.

 

Interesting! I'm looking forward to read the result.

My concern is that some bacteria produces histamine, and many ME/CFS patients are sensitive to histamine. I have tried multiple probiotics last years, also a supplement that was similar to GutMagnific, but I get bad reactions that lasts for weeks. My stomach nearly always respond well to probiotics, but my body starts a terrible stress respons every time, that again strengthen my ME/CFS.
I believe the right bacteria culture can reduce some symptoms. I haven't find it yet and have given up trying. Is GutMagnific "the one"? I'm not sure about that. But hey, prove me wrong!