By Richard Podell, M.D., MPH. www.DrPodell.org
As there is almost no government or pharmaceutical funding for clinical research on ME/CFS, I often search PubMed.gov 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.)
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.
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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 ProHealth.com, Phoenix Rising, or the ME-Global Chronicles e-mail newsletter. (To join contact: firstname.lastname@example.org)
Cons: One 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