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A Commercially Available Probiotic Reduces Chronic Fatigue Syndrome's Inflammation-Should we offer this as a Treatment?

  [ 32 votes ]   [ 5 Comments ]
By Richard Podell, M.D., MPH - • • March 21, 2015

A Commercially Available Probiotic Reduces Chronic Fatigue Syndrome's Inflammation-Should we offer this as a Treatment?. Image courtesy pixabay
Image courtesy pixabay
By Richard Podell, M.D., MPH.
As there is almost no government or pharmaceutical funding for clinical research on ME/CFS, I often search to review new treatments that are emerging in other fields.
My focus today is on a specific probiotic called Bifidobacterium infantis 35624.  In a well-designed double blind study this probiotic demonstrated biochemically measurable anti-inflammatory effects for patients with chronic fatigue syndrome, ulcerative colitis and psoriasis.  Its potential toxicity is low, and—wonder of wonders—one can buy it online and at most drug or health food stores.
Does B infantis 35624 also improve ME/CFS clinical symptoms?  We don’t know. That wasn’t studied.  Maybe next time.
Here’s a summary of what this study tells us:
Several species of probiotics, including Bifidobacteria have been shown to up-regulate an important type of immune cell called regulatory T-cells. Therefore, Irish researchers asked whether B infantis 35624 might be able to reduce the blood level of inflammatory mediators among persons whose illness likely has an inflammatory component.
The subjects of this double blind trial included 48 patients with CFS. Diagnosis was based on the Center for Disease Control Criteria. There were also 22 patients who had ulcerative colitis and 26 with psoriasis. Researchers measured the blood levels for three inflammatory mediators: C-reactive protein (CRP), Tumor Necrosis Factor alpha (TNF-alpha) and Interleukin 6 (IL-6).
At baseline all three inflammatory markers tended to be higher among patients compared to healthy controls.
Subjects then took one packet daily containing either ten billion colony forming units (cfu) of B infantis 35264 or a placebo.  For CFS and psoriasis patients the study lasted 8 weeks. For Ulcerative Colitis patients, the duration was 6 weeks.
(Please note that B infantis 35264 is available under the brand name Align. The dose used in the Irish study was 10 billion colony forming units daily. Align comes in capsules of one billion cfu.)
The Results:
CRP: For all three diseases CRP levels declined significantly among subjects taking the probiotic compared to those taking placebo. For chronic fatigue syndrome the P value was 0.0285. The majority of CFS patients showed a decrease in their CRP.
Tumor Necrosis Factor Alpha: TNF alpha levels declined with probiotic compared to placebo for subjects with CFS and for Psoriasis. TNF alpha did not decline for patients with ulcerative colitis. For CFS P=0.0214.
Interleukin 6: IL6 levels were significantly lower among CFS patients fed probiotic compared to placebo (P=0.054). IL6 declined significantly with B. infantis compared to placebo for ulcerative colitis. IL6 did not decline significantly among patients with psoriasis.
The Key Article:  Greoger, D…..Quigley, M., Bifidobacterium infantis 35624 modulates host inflammatory processes beyond the gut, Gut Microbes, 2013, 4(4):325-339.
You can download the full article online for free HERE.
Here’s my take on what we have tentatively learned:
Bifidobacteria infantis 35624  at 10 billion cfu per day taken for 8 weeks  tends to reduces three markers of  systemic inflammation, CRP, TNF alpha, and IL6.  Please note: this conclusion has two parts. One: B. infantis 35624 has anti-inflammatory actions. Two: these anti-inflammatory effects are not limited to the gut—where probiotics live. Rather they affect the body systemically. 
Did the patients who were took B infantis 35624 tend to feel better than those on placebo?  I emailed the lead author, Dr. Quigley, about this. He confirmed that his group did not collect any data on clinical outcomes. He explained that to do so would have required a considerably more expensive study.
Critical Question Addressed to All Readers: Does anyone know a high executive at Proctor and Gamble—the producer of the Align brand of B infantis 35624? Align has supported several clinical studies. If their product truly helps CFS, psoriasis and or ulcerative colitis that could certainly expand their potential market.
Is anyone likely to fund a repeat of the Irish study to confirm its biochemical results? More important to us—Will anyone fund an extension of this study to include clinical end points? We should be grateful to Dr. Quigley and his team from University College, Cork, Ireland. Wouldn’t it be wonderful if we could help raise funds to enable Dr. Quigley’s team to do a follow up study?
Open Question:  Should clinicians who treat ME/CFS offer patients the option of taking Align or, if available, another brand of  B. infantis 35624?
Pro: As interventions go, adding a probiotic is relatively safe.  Taking B. infantis 35624 might or might not help; but it’s not likely to cause major harm. If a significant number of people with ME/CFS report that they improve that could create support for a double blind study. For example, if people were to post their experience on ME/CFS chat rooms such as, Phoenix Rising, or the ME-Global Chronicles e-mail newsletter. (To join contact:
ConsOne small double blind study without clinical end points isn’t much to go on.  Also, please note that the dose used in this study (10 billion cfu) was ten times higher than the dose in one capsule of Align (one billion CFU). Ten billion cfu is fairly expensive. Currently Target sells forty two one billion cfu capsules of Align for about $37.  So a 6 week trial of 10 billion cfu would cost about $370 or about $250 per month.  Pricey, but perhaps worth it, if it makes a difference.
If one were to work up to the high dose of 10 billion cfu daily, it should be done in steps to minimize GI side effects. I strongly recommend collaboration with a qualified clinician. 
Richard Podell, M.D., MPH
Clinical Professor Dept of Family Medicine
Rutgers-Robert Wood Johnson Medical School

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Article Comments Post a Comment

Let's Generalize a Bit
Posted by: Webmind
Nov 25, 2015
Silly to go out and take this one strain of probiotic. Go out and get the most powerful probiotic formula you can find and take as many different strains as possible. Who knows which one will be helpful?

I can tell you that as someone who has suffered severe ME/CFS/Fibro for almost 10 years, I'm not sure anything has had the huge impact in promoting a return to health as probiotics (probably colostrum every day is also hugely important).

Take them and watch your body work its magic. They are safe so if taking a little doesn't help try taking more. You also must exercise vigorously every day (no matter how painful it is to start) and detox your body in every way possible.

Good luck to all.
Reply Reply

not all probiotics are good - get rid of Lacto-bacillus
Posted by: Sandy10m
Feb 15, 2016
For my ME/CFS and IBS issues, I found that regular Lacto-bacillus bacteria (in yogurt and almost every probiotic formula) are DEADLY to my body. I have been using 2 main forms of probiotics. The first is pure BIFIDUS bacteria from Jarrow (no Lacto at all). The other is a really exotic probiotic from Germany called MUTAFLOR. Mutaflor has a really interesting history, discovered in WW1 in the stool of an orderly that never got sick, even though he cared for the sick. This combination, along with many supplements, has helped me regulate my IBS without making it worse. If you have uncontrolled IBS, switch from LACTO-based probiotics to BIFIDUS-based ones. I won't go back. Good luck everyone.


a caution re probiotics
Posted by: AuntTammie
Jan 13, 2016
While they are very beneficial for many, there are a lot of ME/CFS patients who find they have big problems with taking them. (And for some those problems do not go away once the probiotics are stopped) That may be because some of the byproducts of probiotics include H2S (a neurotoxin) and lactose or lactase (sorry I forgot which one) and ME patients' bodies do not do a good job of getting rid of these ....there are a few other potential reasons as well, but thanks to brain fog, I am not currently remembering them.

I have really researched this, though, because when I first tried taking probiotics, I got a lot worse. I stuck with them thinking that it was just the initial reaction and that perhaps I was having a herx reaction, too. The end result was that I developed gut issues I had never had, and I also woudn up with several other aspects of my ME getting significantly worse. The gut issues got so bad, I literally almost died form them. And, the other issues never completely improved even after yrs without the probiotics.

I couldn't figure out why since they seem so safe and are pushed so much as being beneficial (and like I said for many, they are). I found that I am far from being the only one who has had these issues. I also gave a different brand of them another try yrs later at my Dr's insistence. And, even he woudn up agreeing that they are not a good idea for me.
Reply Reply

Works 4 me
Posted by: mikiem
Mar 30, 2016
Anecdotal evidence/experience of course, 2 capsules of Align per day over 3-4 months helped what were diagnosed as psoriasis symptoms with some level of autoimmune involvement. Change was not noticeable with 1 capsule/day -- stuff is expensive so didn't try it with 3/day. [cheapest thru Amazon but can only order in cold months per anecdotal evidence supplied by reviewers, based on theory that exceedingly high temps during postal delivery destroyed bacteria].
Reply Reply

Former fibro/CFS Pt
Posted by: OhYouKnow
Oct 11, 2017
Why didn't you tell me this when I saw you in your office in Summit, NJ at Overlook ten years ago? Why don't you contact your former patients to tell them, if this is a breakthrough? If you really stand by this treatment, please contact with me and I am more than happy to make a telemedicine appointment with you for a follow-up and Tx plan.
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