Canada Halting Mutaflor

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sean88
Regular Member


Date Joined Jul 2012
Total Posts : 210
   Posted 3/15/2013 4:15 AM (GMT -7)   
I called the company in Canada that sells Mutaflor and they told me they had been given a 30 day notice from the government to stop selling it. Something about requiring additional studies but nothing related to safety apparently. Of course these studies were cost prohibitive for such a niche product so neither the manufacturer nor the distributor can afford to do these studies. FWIW they are having a fire sale on the stuff so I got a 4 mo supply.
Left side UC diagnosed 2009
SCD since March 2011
Meds - Colazal, Rowasa, LDN
Supplements - D 5000IU, Fish Oil, Multivitamin
Probiotics - SCD Yogurt, Kefir, Sauerkraut, Kimchi, 299v, L GG, BC30, reuteri, salivarius

Levi
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Date Joined Nov 2009
Total Posts : 1615
   Posted 3/15/2013 5:28 AM (GMT -7)   
Great, I just read a couple of days ago how an e-coli strain like in Mutaflor can really enhance the effectiveness of TSO, whipworms, for people using helminthic therapy. I'm pretty sure it's already been cancelled in the US.
29 years old
Diagnosed 2009 proctosigmoiditis, 2010 Crohn's colitis, 2011 ileocolitis
Symptoms since 10.2007
Pentasa, four grams/day, 6mp 50 mg/day
Rowasa enema, 3 grams every other night
VSL#3 DS one packet/day and VSL#3 yogurt
Turmeric, digestive enzymes, boswellia, propolis, cat's claw, l-glutamine, fish oil, vitamin D, kefir, blueberries
Liver-Milk Thistle; Heart-Hawthorn, sometimes

TheAnswersYouSeek
Veteran Member


Date Joined Jan 2013
Total Posts : 2543
   Posted 3/15/2013 1:58 PM (GMT -7)   
Department of Gastroenterology, Hvidovre University Hospital, Copenhagen, Denmark-----Treatment of Inflammatory Bowel Disease Associated E. coli with Ciprofloxacin and E. coli Nissle in the Streptomycin-Treated Mouse Intestine
http://www.plosone.org/article/info%...l.pone.0022823

Maintaining remission of ulcerative colitis with the probiotic Escherichia coli Nissle 1917 is as effective as with standard mesalazine.
University of Cologne, Germany: http://www.ncbi.nlm.nih.gov/pubmed/15479682

Probiotic Escherichia coli strain Nissle 1917 outcompetes intestinal pathogens during biofilm formation. (Mutaflor) http://www.ncbi.nlm.nih.gov/pubmed/20110388#

Probiotic Escherichia coli Nissle 1917 Inhibits Leaky Gut by Enhancing Mucosal Integrity http://www.plosone.org/article/info%...l.pone.0001308


Mutaflor was too awesome so the drug companies decided to kill it by making it go through the process of being classified as a biologic. Who knows what will come of it. Political bullcrap
Current: No Dairy, Sugar, Wheat or Soy.. Olive leaf (20% Oleuoropein), Lauricidin/monolaurin, NA-Cysteine, CoQ10, Psyllium/Apple pectin, Ferula, Triphalia, Metagenics, methylation pathway support.
Things that have helped: Cleansing Enemas, Probiotic retention enemas, slippery elm, marshmellow root, aloe, Oil of Oregano (80%+ carvacol), Threelac

TheAnswersYouSeek
Veteran Member


Date Joined Jan 2013
Total Posts : 2543
   Posted 3/15/2013 2:07 PM (GMT -7)   
This was of interest to me as I have a latent Strep infection that nobody has caught until now... I was only able to get one round of mutaflor before it was discontinued here. It helped more then VSL ever has.

London Lurker
Veteran Member


Date Joined Feb 2013
Total Posts : 715
   Posted 3/15/2013 3:47 PM (GMT -7)   
I don't get this. Having just got a friend in Germany to look into this for me, Mutaflor is on sale in just about every pharmacy in Germany. If there were any safety concerns, I am sure that the Germans would not allow it to be sold.

Why on earth would it be banned when other probiotics are openly sold in North America?
Proctitis 1984
Pan Colitis 1988
No major flare ups since, many well years among the mild to moderate flare ups, some years without meds
No special diet other than low fibre and rare alcohol
Currently Mezavant XL x 2 per day
Salofalk Enema x 1 per day
B complex supplements
Vitamin D and vitamin K2
Probiotics sometimes

1 month in current flare which is suspected C Diff :-(

DBwithUC
Veteran Member


Date Joined Feb 2011
Total Posts : 1687
   Posted 3/16/2013 9:43 PM (GMT -7)   
Well, there is the whole "possibility of death" side effect.

There is a toxic effect that can cause genetic damage, and attempts to get the beneficial effect and skip the toxic side effect have been unsuccessful. It does help, but is also has risks. This is a bad bacteria that is a double sided sword. It is not the cuddly friendly bacteria like many other probiotics.

Genotoxicity of Escherichia coli Nissle 1917 strain cannot be dissociated from its probiotic activity Gut Microbes 3:6, 1-9; November/December 2012

"Our results together with previous studies20-23 and clinical trials13-
15 confirm the therapeutic potential of this E. coli Nissle
1917 strain in promoting gut homeostasis upon mucosal injury.
This probiotic was regarded, so far, as nonpathogenic,11 but we
have shown that this bacterial strain induce DNA double strand
breaks and chromosomal abnormalities in eukaryotic cells. Even
if in vivo genotoxicity of this probiotic strain remains to be investigated,
we hypothesized that construction of a non-genotoxic
mutant of E. coli Nissle 1917 could improve its safety. However,
we were unable to dissociate the genotoxic activity of the strain
from its probiotic activity since inactivation of the biosynthetic
pathway leading to the production of Colibactin abrogated also
the probiotic activity in two different models of experimental
colitis." .... "Since the genotoxic activity of E. coli Nissle 1917 cannot be
dissociated from its probiotic activity, safety considerations about
large-scale use of this probiotic strain have to be re-evaluated."


Maybe this is a drug company conspiracy, but maybe there are legitimate safety concerns. So in addition to increased risk of colorectal cancer, there is also the risk of genetic damage.

Maybe they should not pull it, but instead make it prescription and have an advisory caution.

TheAnswersYouSeek
Veteran Member


Date Joined Jan 2013
Total Posts : 2543
   Posted 3/16/2013 10:17 PM (GMT -7)   
I hadnt seen that study. They pulled mutaflor here in the us several months ago after nothing but years of stellar research. Maybe it was a blessing that I never got a long trial on it. It sucks though because Mutaflor has been around for awhile and I know many who have used it during their treatment of autism. :( We've been doing clinical trials and lotsa research on this bug since the 80s...

Important info, thanks for sharing.
Current: No Dairy, Sugar, Wheat or Soy.. Olive leaf (20% Oleuoropein), Lauricidin/monolaurin, NA-Cysteine, CoQ10, Psyllium/Apple pectin, Ferula, Triphalia, Metagenics, methylation pathway support.
Things that have helped: Cleansing Enemas, Probiotic retention enemas, slippery elm, marshmellow root, aloe, Oil of Oregano (80%+ carvacol), Threelac

Probiotic
Veteran Member


Date Joined Mar 2007
Total Posts : 2800
   Posted 3/17/2013 4:22 AM (GMT -7)   
Sigh, saves me another smuggling errand run up to Toronto I guess- to be honest I had been using it on and off (mostly on) for the last year without noticing it either helped or worsened me- was excited when I began it.
"In order to save the village organ, we had to destroy remove it" -- Doctor's Prescriber's proverb.

London Lurker
Veteran Member


Date Joined Feb 2013
Total Posts : 715
   Posted 3/17/2013 3:06 PM (GMT -7)   
Same report also states...

"Our data provide additional evidence for the benefit of this currently used probiotic in colitis but remind us that an efficient probiotic may also have side effects as any other medication"

From what I can see this possible side effect is theoretical - we know all about the bad non-theoretical side effects from most of the meds out there. I would be amazed at the Germans letting this be marketed to children (there is a junior version) if there was a serious risk.

Probiotic
Veteran Member


Date Joined Mar 2007
Total Posts : 2800
   Posted 3/17/2013 9:09 PM (GMT -7)   
My theory is the FDA (US Food and Drug Admin) one- some knucklehead at FDA HQ arbitrarily misclassified mutaflor, an OTC probiotic with eons of safety data, as a "drug" (biologic drug at that, L M A O) leading to its being banned in the U.S. owing to lack of multimillion dollar monkey trials, human clinical trials, etc.... When they discovered that it was available OTC in the Great White North that was too much for that particular knucklehead to bear, knowing that people were smuggling it across routinely, so he made noises, and some nimrod at Canada's equivalent to the FDA was coaxed into aligning their regs with the US regs. Just my theory.

Post Edited (Probiotic) : 3/18/2013 9:30:05 PM (GMT-6)


Lodi
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Date Joined May 2012
Total Posts : 680
   Posted 3/18/2013 10:28 AM (GMT -7)   
Sean,

Which company do you buy Mutaflor from? I buy from Medical Futures Inc. I just called to order some and the person who I talked to hadn't heard about this ban. She promised to talk to her manager and get back to me by phone. When I hear from them, I'll report back

They have a promotion on at the moment, $46.88/box if you buy four. The expiry date is October so it worked out well for me since I'm almost out. I take two per day which works out to a box every month.

Anyway, thanks for the heads up!
diagnosed (colonoscopy/biopsy) Feb 2012; U/C throughout entire colon but only partly inflamed?
Big flare right now, on oral prednisone, imuran, mesasal, VSL#3. Mutaflor
I avoid gluten and dairy, I eat pasture raised meat ; some produce; avoid processed food as much as possible; I use olive oil, coconut oil

sean88
Regular Member


Date Joined Jul 2012
Total Posts : 210
   Posted 3/18/2013 3:40 PM (GMT -7)   
Oh wow Lodi. I talked to a gentleman named Raj and he was very clear in saying that the Canadian authorities had given them a 30 day notice. He also said they were having a fire sale and I think I got about the same price you quoted for the 4 boxes. It would certainly be great if he was somehow mistaken.

BTW, have you ever thought about making a yogurt from the Mutaflor? I was trying to think of ways to use it if it is indeed impossible to get in NA.
Left side UC diagnosed 2009
SCD since March 2011
Meds - Prednisone taper(60mg), Colazal, Rowasa, LDN
Supplements - D 5000IU, Fish Oil, Multivitamin
Probiotics - SCD Yogurt, Kefir, Sauerkraut, Kimchi, 299v, L GG, BC30, reuteri, salivarius

Lodi
Veteran Member


Date Joined May 2012
Total Posts : 680
   Posted 3/18/2013 5:59 PM (GMT -7)   
I got a call back from Medical Futures and there is something going on with regulations. Health Canada has not banned it's sale (at least not yet). Let's keep our fingers crossed that this probiotic will remain available here. I

I haven't tried making yogurt from them, I just take them along with my yogurt. Are you going to try it?

I'm actually confused as to which probiotics to take, I'm just taking what other people recommend , namely Mutaflor and VSL#3, yogurt and sauerkraut. I can't even say they are helping me, just going under the premise that they should be helping.
diagnosed (colonoscopy/biopsy) Feb 2012; U/C throughout entire colon but only partly inflamed?
Big flare right now, on oral prednisone, imuran, mesasal, VSL#3. Mutaflor
I avoid gluten and dairy, I eat pasture raised meat ; some produce; avoid processed food as much as possible; I use olive oil, coconut oil

London Lurker
Veteran Member


Date Joined Feb 2013
Total Posts : 715
   Posted 3/18/2013 6:08 PM (GMT -7)   
I have seen this page about growing it but you need the suspension, not the pills
www.drmyhill.co.uk/wiki/Growing_Mutaflor

sean88
Regular Member


Date Joined Jul 2012
Total Posts : 210
   Posted 3/18/2013 6:12 PM (GMT -7)   
Okay, maybe it was a sales pitch to get me to buy a larger quantity :). I hope so anyway.

I made a few batches of yogurt from my last box this past fall. It looked fine although there was no enteric coating so not sure how effective it would be compared to the pills.

I'm pretty much the same as you WRT taking probiotics. I think they help and have read a lot of literature that looks promising. I do the sauerkraut as well and the yogurt and also some kefir.
Left side UC diagnosed 2009
SCD since March 2011
Meds - Prednisone taper(60mg), Colazal, Rowasa, LDN
Supplements - D 5000IU, Fish Oil, Multivitamin
Probiotics - SCD Yogurt, Kefir, Sauerkraut, Kimchi, 299v, L GG, BC30, reuteri, salivarius

mindoverbutter
Regular Member


Date Joined May 2011
Total Posts : 232
   Posted 3/19/2013 2:46 PM (GMT -7)   
sean, how are you getting the 4 months supply into NA?
22/m dx May 2009 chronic ulcerative colitis (whole colon)
dx April 2011 leftsided colitis (rest of colon appears normal)
2 Lialda 2x daily
1/11 SCD w/ homemade RAW Goat Milk Yogurt & Freeda Multivitamin
bananas, avacado, spinach, all proteins, carrots, heaps of ginger & garlic, almond flour breads, raw honey
1/13 Pred @ 30mg. 4/8 Off the pred!!! Yay!
SCDophilus 10 bil CFU
JR's Brasco Broth

sean88
Regular Member


Date Joined Jul 2012
Total Posts : 210
   Posted 3/19/2013 3:40 PM (GMT -7)   
MOB, do you mean how am I getting the mutaflor back into the US from Canada? It's a bit touch and go at the border but there's a provision which allows the Customs agents to allow a 3mo supply for personal use to cross the border. The last time I did it the topic didn't come up. If it does I plan on starting with saying that I picked up some probiotics and if they dig deeper then I will fess up and pull out the document from the FDA that talks about the latitude that the agents have for personal use. Oh, and I have a friend just over the border who is willing to receive the package and refrigerate it until I can pick it up.
Left side UC diagnosed 2009
SCD since March 2011
Meds - Prednisone taper(60mg), Colazal, Rowasa, LDN
Supplements - D 5000IU, Fish Oil, Multivitamin
Probiotics - SCD Yogurt, Kefir, Sauerkraut, Kimchi, 299v, L GG, BC30, reuteri, salivarius

Probiotic
Veteran Member


Date Joined Mar 2007
Total Posts : 2800
   Posted 3/19/2013 4:01 PM (GMT -7)   
Sean888 I am like you.. i have not said a word when bringing it over. I carry a letter from my GP explaining it is for personal use in case I am ranndomly checked and they ask what the heck is it, but I'm sure they wouldnt be happy that I didnt declare it- however what can ya do- if you do that they might confiscate it in a warehous while you wait days to get an answer from their DC headquarters and by that time the lack of refridgeration coukd ruin the potency.
"In order to save the village organ, we had to destroy remove it" -- Doctor's Prescriber's proverb.

Lodi
Veteran Member


Date Joined May 2012
Total Posts : 680
   Posted 3/19/2013 5:48 PM (GMT -7)   
My five boxes arrived today:-) .

It wasn't a sales pitch, there is an issue and it may not be able to be sold here. I just said it wasn't banned (yet). The problem is how it's classified and labelled as per health Canada regulations. There's still a possibility it won't fall into the pile.

Does anyone know why the sale of Mutaflor was stopped in the US? It could be the same issue that we're facing in Canada. If that's the case, we should still be able to import it from Germany. Oh, except the refrigeration...duh.

Sean, are you still doing that antiflammatory diet? How's it going? Can I ask what's the meaning of those last few things on your signature?

TheAnswersYouSeek
Veteran Member


Date Joined Jan 2013
Total Posts : 2543
   Posted 3/19/2013 6:11 PM (GMT -7)   
I bet it was pulled in the us right after the study dbwithuc cited above..I seem to remember late summer
Current: No Dairy, Sugar, Wheat or Soy.. Olive leaf (20% Oleuoropein), Lauricidin/monolaurin, NA-Cysteine, CoQ10, Psyllium/Apple pectin, Ferula, Triphalia, Metagenics, methylation pathway support.
Things that have helped: Cleansing Enemas, Probiotic retention enemas, slippery elm, marshmellow root, aloe, Oil of Oregano (80%+ carvacol), Threelac

sean88
Regular Member


Date Joined Jul 2012
Total Posts : 210
   Posted 3/20/2013 3:05 AM (GMT -7)   
@Lodi - Yes, still on the AID and still seeing the nutritionist form UMass. Been in a low grade flare for a while so not sure if it's helping it from getting worse or not doing much. I figure at least it's good for the rest of my health even if not the UC. Do you mean the weird latin sounding names in my sig or the symbols?

299v - L plantarum from Jarrows
L GG - L rhamnosus GG aka Culturelle
BC30 - B coagulens from Digestive Advantage
reuteri - L reuteri from Biogaia
salivarius - L salivarius from R-Garden
Left side UC diagnosed 2009
SCD since March 2011
Meds - Prednisone taper(60mg), Colazal, Rowasa, LDN
Supplements - D 5000IU, Fish Oil, Multivitamin
Probiotics - SCD Yogurt, Kefir, Sauerkraut, Kimchi, 299v, L GG, BC30, reuteri, salivarius

Lodi
Veteran Member


Date Joined May 2012
Total Posts : 680
   Posted 3/20/2013 1:54 PM (GMT -7)   
sean, yes, I was talking about all 5 of those thing you listed. If you have the time it would be interesting to hear about what they are and what they're supposed to help with.

As far as the food (yogurt, kefir, sauerkraut and kimchi, are you making those on your own? I forget. If not, which brands are you buying?

I think you are bang on about the diet. It seems excellent. When you started it were you on prednisone, or did you end up on that more recently? Sorry if I'm asking too much, I just really liked the approach of the UMass study and I'm curious about how it's panning out.

Best.
diagnosed (colonoscopy/biopsy) Feb 2012; U/C throughout entire colon but only partly inflamed?
Big flare right now, on oral prednisone, imuran, mesasal, VSL#3. Mutaflor
I avoid gluten and dairy, I eat pasture raised meat ; some produce; avoid processed food as much as possible; I use olive oil, coconut oil

sean88
Regular Member


Date Joined Jul 2012
Total Posts : 210
   Posted 3/20/2013 6:42 PM (GMT -7)   
All of those probiotics show positive results for UC but only in small trials or animal trials. I did investigations mostly on pubmed to find articles about these. I can send links if you are interested.

I make all my own fermented foods. I make the yogurt and kefir by methods that reduce lactose to nil. Really easy to make these in large batches.

Only started a pred taper last week so wasn't on it when I started the AID.

Ask away. It's great that we can share our experiences.
Left side UC diagnosed 2009
SCD since March 2011
Meds - Prednisone taper(60mg), Colazal, Rowasa, LDN
Supplements - D 5000IU, Fish Oil, Multivitamin
Probiotics - SCD Yogurt, Kefir, Sauerkraut, Kimchi, 299v, L GG, BC30, reuteri, salivarius

Lodi
Veteran Member


Date Joined May 2012
Total Posts : 680
   Posted 3/20/2013 8:20 PM (GMT -7)   
I'll read the PubMed articles if you post them...others might be interested too. Thanks! I can also just write the names of the probiotics down and I'll look them up if I decide to take more. I'm spending over $300 a month on VSL and Mutaflor as it is so I don't know if I can afford to add more.

I make my own 24 h yogurt without problems, but I haven't had any luck with kefir. How do you make yours and is it effervescent? I used to absolutely love kefir before I got UC then all of a sudden I didn't seem to be able to tolerate any dairy as in it triggered D shortly after ingesting it. I've tried commercial kefir twice in the last year - no luck. I'm tolerating yogurt though. Twice a day I mix my VSL in a couple of tablespoons of the 24h yogurt and things are improving, no D triggered afterwards.

Just from a financial perspective I think making my own probiotics is going to be the way to go plus, didn't the people in the UMass study say there's more bacteria in the homemade stuff? Are you eating the veggies with mostly every meal? How about the supplements, do you take them all at once? throughout the day?

I've dabbled a bit with making my own fermented veggies (mostly carrots, daikon root, radish and garlic) last fall and they were so delicious but the flare I was in got so bad that I stopped eating them. I think I'll try to make some again. I buy Bubbies sauerkraut and try to eat some every day but I don't always remember and it's not as good as my own stuff. Do you have a recipe for your kimchi?
diagnosed (colonoscopy/biopsy) Feb 2012; U/C throughout entire colon but only partly inflamed?
Big flare right now, on oral prednisone, imuran, mesasal, VSL#3. Mutaflor
I avoid gluten and dairy, I eat pasture raised meat ; some produce; avoid processed food as much as possible; I use olive oil, coconut oil

sean88
Regular Member


Date Joined Jul 2012
Total Posts : 210
   Posted 3/21/2013 3:52 AM (GMT -7)   
Here are a few articles for each probiotic. If you want the rest I'm going to have to share out my Evernote Notebook :).

www.ncbi.nlm.nih.gov/pmc/articles/PMC1175894/

www.ncbi.nlm.nih.gov/pubmed/11136273

www.ncbi.nlm.nih.gov/pmc/articles/PMC2291386/?tool=pmcentrez

www.ncbi.nlm.nih.gov/pubmed/22014083

en.wikipedia.org/wiki/Lactobacillus_reuteri

For kefir I use Dom's recipe for low lactose batches. Really easy to make once you have the grains. Really economical too. The kefir crowd is great about sharing grains. I would stay away from commercial.

users.chariot.net.au/~dna/Makekefir.html#Storing

I'm like you WRT the fermented veggies. I shy away when I'm in a flare. And then I gradually start back as I feel better. Go slow reintroducing them.

I take my supplements in the AM spaced out by 20-30min.

This is my favorite kimchi recipe although I add less red pepper and skip the fish sauce.

drbenkim.com/how-make-kim-chi.htm
Left side UC diagnosed 2009
SCD since March 2011
Meds - Prednisone taper(60mg), Colazal, Rowasa, LDN
Supplements - D 5000IU, Fish Oil, Multivitamin
Probiotics - SCD Yogurt, Kefir, Sauerkraut, Kimchi, 299v, L GG, BC30, reuteri, salivarius
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