A reader posted about this new to the market probiotic on CFS Remission’s Facebook. It is promoted by “The Gut Health Protocol“. The site also sells a book. The scope of the book is general health issues and not CFS/IBS/FM specific.

You may wish to read Phages 101 before reading more.

Bad/Misleading Advertising Copy

“Contains a completely safe phage complex that is scientifically shown to selectively kill certain strains of “bad” bacteria, does not harm our beneficial bacteria, and supports a healthier microbiome. ”  I have contacted him with the following question:

• “Please list the strains of these bad bacteria.
• Please provide the citations that shows that it does not harm good bacteria. My readings state that there is no such thing. Lactobacillus reduce Bifidobacterium –  which are good ones.. “

What is in it?

The label lists 7.5 billion CFU of the following without percentages.

• Lactobacillus plantarum
• DE111 (Bacillus subtilis)
• Lactobacillus rhamnosis
• Bifidobacterium longum
• Bifidobacterium bifidum

And 15 mg of a Phage complex

• LH01 – Myoviridae
• LL5 – Siphoviridae
• T4D – Myovirdae
• LL 12 – Myoviridae

DE111 is available in 5 Billion CFU capsules elsewhere (site) which provides citations – and may be the firm where it is manufactured. No strains are listed on the others 😦 .

As a side note, IMHO Kyo-Dophilus9 is a better blend (with 180 capsules for $32 versus $50 for 60 capsules for this product), significantly cheaper per Billion CFU.

The Phages

This is an interesting aspect, so over to PubMed. My understanding of phages are that they are very specific and not broad in their action. “They have been used for over 90 years as an alternative to antibiotics in the former Soviet Union and Central Europe, as well as in France.^{[5]” [Wikipedia]}

So what do we know about these living VIRUS infections, have there been any human safety studies for these specific viral infections?

• LH01 – Myoviridae – NOTHING
• LL5 – Siphoviridae – NOTHING
• T4D – Myoviridae – 9 Results
  • Lytic infection of Escherichia coli biofilms by bacteriophage T4.[1995] This implies that it will kill some E.Coli, which is not good when you likely have very few. Lytic — means killing
• LL 12 – Myoviridae – NOTHING

According to this web site, all of the above kills E.Coli.  Very not good for CFS/FM.

A second issue with this is simple “The treatment is not approved in the US” [2013] with the exception of Washington and Oregon when done by a licensed naturopathic physician. [wikipedia]

FDA Approval?

• Your search – site:fda.gov LH01 Myoviridae – did not match any documents.
• Your search – site:fda.gov t4D Myoviridae – did not match any documents.
• Your search – site:fda.gov LL12 Myoviridae – did not match any documents.
• Your search – site:fda.gov LL5 – Siphoviridae – did not match any documents.

Other phages are cited “Intralytix reports that five of the phages are classified under the order Caudovirales, family Myoviridae, and are designated LMSP-25, LMTA-34, LMTA-57, LMTA-94, and LMTA-148.” [Source]

Recommend Testing BEFORE using

Lab tests for level of E.Coli (good and bad) should be done before using (see this example). For example,  GanzImmun Diagnostics AG. or MVZ Institute for Micro Ecology GmbH.

• If you are low, the phages above may result in extinction of your E.Coli. Since E.Coli probiotics are not available in the US (and take up residence in only some people) —  you may end up making your condition permanent, at best, greatly reduce your odds of going into remission.
• If you are high, your medical professional can have the strains you have tested for susceptibility to the above phages… you may be headed toward evolving to Crohn’s disease.
  • Pathogenic Role of Associated Adherent-Invasive Escherichia coli in Crohn’s Disease[2017].
  • Bacteriophages targeting adherent invasive Escherichia coli strains as a promising new treatment for Crohn’s disease [2017].

Without adequate testing to determine if these phages are appropriate (instead of harmful), blind taking runs significant risks to many. Remember “Escherichia coli (E. coli) is a bacteria that normally is an important part of the healthy intestinal tracts of humans and animals. However, there are some kinds(1-3%) of E. coli that are harmful and can cause disease.” [CDC]

Bottom Line

I give this a thumbs down for several reasons:

• High cost, much cheaper alternatives are there
• The inclusion of at least one of the cited phages is harmful to the goal of restoring a healthy level of E.Coli bacteria
• The appearance of ignoring the laws, rules and regulation in the US and selling direct to the public – including interstate commerce (combined with misleading copy writing)… it is just a matter of time before legal action is likely to occur. He sells his books on Amazon — he sells this direct. I speculate that Amazon would pull it quickly off their website if he tries selling there. It appears to be technically an illegal product.