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Crohn's Disease Forum » Books, Multimedia, Research & News » MAP Vaccine Ready for Human Trials - Could be Used for Crohn's


 
12-24-2016, 07:59 AM   #871
DamnitCrohns
 
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I would still very much like to know what's going on with the vaccine.

Phase I trials were supposed to start earlier this year and were delayed due to a manufacturing pickup. IŽd love to know what's the current news on this as the website hasn't been updated in a while...
Agreed, they seem to have stopped doing the newsletters now, which makes me think there have been further delays or something.
12-25-2016, 12:09 AM   #872
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The Crohn's MAP vaccine effort is pretty unique. They have been crowd-funding part of their effort for a few years now, so there is an expectation from the community that they should be kept in the loop. Yet the CMV folks need to pursue a careful scientific approach if they are to attract serious consideration. I really know nothing, and may be talking out of my hind end, but to me it almost feels like they're stalling to see how the RedHill trials pan out, with some meaningful data slated for the first part of next year.

I wish anyone wishing to crack the Crohn's nut all the success in the world. I take a wait-and-see attitude on the MAP hypothesis.
12-25-2016, 05:21 PM   #873
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I really know nothing, and may be talking out of my hind end, but to me it almost feels like they're stalling to see how the RedHill trials pan out, with some meaningful data slated for the first part of next year.
I don't think that is the case. I am quite sure if the Vaccine and MAP Test had been ready they would have preferred to get ahead of Redhill, not wait for their results. Unfortunately, I suspect the silence is not good news.
12-27-2016, 03:40 PM   #874
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I don't think that is the case. I am quite sure if the Vaccine and MAP Test had been ready they would have preferred to get ahead of Redhill, not wait for their results. Unfortunately, I suspect the silence is not good news.
I agree JMC, which is unfortunate. I am hoping for some news of SOMETHING in 2017. A relative of mine who is in medical school was sharing some of his notes regarding what he was being taught about IBD - from a top school here in the US. It was all about microbiome shifts and causes being dietary and environmental as big factors, not only nature tendencies (i.e. genetic). I thought that was interesting that is being taught instead of autoimmunity and that's it. Not sure what that means for people who have it, but let's cross our fingers for some trial results in 2017. I am honestly waiting to hear something about QU Biologics SSI, but haven't heard or read not a single thing.
12-31-2016, 11:04 AM   #875
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I agree JMC, which is unfortunate. I am hoping for some news of SOMETHING in 2017. A relative of mine who is in medical school was sharing some of his notes regarding what he was being taught about IBD - from a top school here in the US. It was all about microbiome shifts and causes being dietary and environmental as big factors, not only nature tendencies (i.e. genetic). I thought that was interesting that is being taught instead of autoimmunity and that's it. Not sure what that means for people who have it, but let's cross our fingers for some trial results in 2017. I am honestly waiting to hear something about QU Biologics SSI, but haven't heard or read not a single thing.
Im a med student near qualifying and we were taught that it was certainly autoimmune, i had a lengthy talk with some of the gastro consultants who all expressed that even if the cause were some infection or antibiotic upset that investigation would definitely not find anything there anymore, the self perpetuating disease is set in motion.
01-02-2017, 12:10 PM   #876
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Scared1, I believe QuBiologics are planning another, bigger trial the first or second quarter of this year. Regarding the vaccine, I don't believe there will be any answers in 2017. Phase 1 is planned to start this January, but it is only on healthy people to make sure it is safe. Phase 2a is planned for the end of the year, but the data will not be analyzed until 2018 (if all goes well).
01-02-2017, 12:21 PM   #877
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Anonymous 77, I don't understand what the GIs are telling you. They think that there can be no chronic infection? If so, how do they explain the mostly positive results people are getting from AMAT?
01-02-2017, 03:11 PM   #878
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I agree with Mommabear. I spoke to my cousin and my husbands GI who graduated from Columbia Medical school and they reiterated what I stated. To say that if it is an infection nothing will come of it is a bit strange of sweeping generalization - there have been instances where dysbiosis or attempting to clear the infection whether AEIC, MAPs etc has shown improvement.
01-02-2017, 08:25 PM   #879
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Im not going into GE so i can only answer speculatively, although they are from a global centre for leading IBD care. The idea is that there is no ongoing infection, just some event, which could be a pathogen,activates a latent immune fault causing autoimmunity to some extent. The initial cause is just temporary but the body is left changed for life.

It happens a lot in autoimmune disease, some negative event leaves the immune system mistakenly self-targeting and nothing short of autologic stem cell transplant would ever totally relieve this.

One consultant stated on the mycobacteria theory that its not a surprise - every time a new type of pathogen comes to academic interest or a microorganism discovered in the body it is proposed as being behind every disease we dont understand, until the hysteria dies down.

I dont know enough to say if its wrong in this case, and i desperately hope it is the cause and we can all be better - but we aren't really seeing that through trial data as it stands unfortunately.
01-02-2017, 10:34 PM   #880
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Thanks for your long answer Anonymous77.

The thing is, the idea that MAP might be behind Crohn's is not new. I believe even Burrell Crohn thought there was a link. And there is in fact a lot of compelling research pointing to MAP as a culprit, but I think a lot of GIs remain glued to the flawed Selby trial to reinforce their beliefs. It's really weird that they hold onto Selby's conclusions despite the many flaws and despite the fact that remission rates were actually higher than in the Humira trials! I am biting at the bit, waiting for Redhill to publish their results which will hopefully change the landscape, at least in regards to the efficacy of AMAT.

And how would they explain the test results that are coming back positive, indicating ongoing bacterial presence, both in tissue and in blood? I think this recent paper from October where the patient actually sheds MAP adds to the arsenal: Concurrent Resolution of Chronic Diarrhea Likely Due to Crohn's Disease and Infection with Mycobacterium avium paratuberculosis. (October 2016).

Also, I thought most GIs were moving away from this idea of autoimmunity. It certainly doesn't explain the massive increase in cases, particularly among children and in Asia. I should think the numbers would remain constant if it were autoimmunity. It's weird that cases would increase so dramatically without some pathogen spreading. In my mind, doctors who blame disease on autoimmunity say that because they don't have an answer. They don't know what else to call it. They should watch Prof. Marcel Behr debunk the autoimmune theory.

I have been looking at Mycobacterium generally and trying to understand it. I am no scientist, so what I understand is probably quite rudimentary, but for people who are infected with Intestinal TB for example, there are so many similarities to Crohn's, including the disease going dormant. But no doctor would argue that a person infected with TB does not have a chronic infection. Also, it seems scientists are just beginning to understand the stealth of these bacteria, hiding deep inside biofilms and escaping detection. The problem is figuring out how to break down these fortresses and getting to them.

Personally, I will need someone to prove that it is NOT MAP for me to look for another culprit for most Crohn's cases, and perhaps AIEC for others. I feel like it is there, in front of these doctors, but they are like faulty immune systems, unable to see it...
01-03-2017, 06:21 PM   #881
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It happens a lot in autoimmune disease, some negative event leaves the immune system mistakenly self-targeting and nothing short of autologic stem cell transplant would ever totally relieve this.
This study found no significant difference between autologous stem cell transplants and conventional therapy for Crohn's: http://jamanetwork.com/journals/jama...rticle/2475462
01-04-2017, 12:44 AM   #882
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It happens a lot in autoimmune disease, some negative event leaves the immune system mistakenly self-targeting and nothing short of autologic stem cell transplant would ever totally relieve this.
It doesn't just happen through some event. Inflammation is very specific in crohn's disease, it's not like in UC where the whole organ is inflamed, crohn's disease features regional transmural inflammation. Early signs of crohn's disease show inflamed peyer's patches that are exclusive to the ileum.

There is no self-antigen you can point to in CD, there is no organ wide tissue inflammation, the type of inflammation resembles intestinal TB and Granulomatous Disease, not UC, the mesentery is involved and genetic predisposition point to autophagy defects. AIEC are consistently found in the ileum of CD patients and dysbiosis is a hallmark of the disease. CD is not consistent with autoimmunity.

There are millions of bacteria active in the ileum, both commensal and increasingly recovered in CD patients, pathogenic bacteria taking advantage of genetic anomalies, those pockets of inflammation seen in crohn's disease are a result of macrophages responding to a microbial antigen and activating T lymphocytes, they are not responding to a self-antigen, crohn's disease does not feature inflammation as seen in UC.

Last edited by kiny; 01-04-2017 at 01:34 AM.
01-04-2017, 01:28 AM   #883
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One consultant stated on the mycobacteria theory that its not a surprise - every time a new type of pathogen comes to academic interest or a microorganism discovered in the body it is proposed as being behind every disease we dont understand, until the hysteria dies down.
MAP targets the ileum in ruminants with Ptb, that's why it's of interest to people who study Croh's disease. It's not "proposed as being behind every disease", no, it causes patchy inflammation of the ileum and weight loss in cows, the same features you find in people with CD, that's why it's relevant to study, we want to know if there's a possibility of a zoonotic disease in people with CD.

Genetic predisposition in CD patients also points to predisposition to mycobacterial infections. That's why the relationship between MAP and Crohn's disease is being looked at. Not because of hysteria.

I've been tested multiple times for the presence of MAP, always negative, yet I would never outright discredit the idea that MAP might be involved in some people with CD. There are far too many similarities between Ptb and CD to throw the theory overboard.

Tell the consultant to make an account on the forum.
01-04-2017, 02:05 AM   #884
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Kiny - Cows and other ruminants have vastly different digestive systems to us, if it was shown in primates it may be interesting but even then i would wait until human trials before getting excited, there are countless pathogens that are damaging in animals and not in us or vice versa. Especially when the disease seems different, with MAP causing ileal inflammation and crohns causing disparate inflammation of all the digestive tract, joints, eyes, potential vitamin synthesis errors and more.

No-one's saying to throw the theory overboard, i was just stating that my experience with the GEs is that they dont retard it likely and they're quite certain it is autoimmune.

I feel there's a desperation here that it isnt autoimmune but rather an infection as this has a better chance of being cured and is less embarrassing - i usually tell people its thought to be an infection for the same reason and i hold out hope this research turns up well, but im not yet convinced.
01-04-2017, 02:45 AM   #885
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Mommabear -The shedding of bacteria could just be the result of crohns disruption leading to dysbiosis, or just that new sensitive tests are finding normal bacterial presence. It may well be MAP is a commensural, normal organism in many people. More rigorous studies are needed to actually show the relationship.

I agree crohns being a granulomatous degree is reminiscent of tb and i would like more follow up there, but one consultant i talked to there suggested the granulomas would be empty of anything abnormal and that it could be like sarcoidosis, which forms granulomas but is also believed to be autoimmune.

Immune diseases certainly are on the rise, both autoimmunity and deficiencies - as i said i dont have much GE experience but i was on placement with a researcher working on the effect of xenooestrogens on human health and there's a strong correlation between increasing western exposure to oestrogens, lowering testosterone and rising immune disease. His study was looking more specifically at certain physical disorders but it was a really interesting side point. Our population today is far more afflicted by immune dysfunction than ever before.

You are right that we are only still working out how mycobacteria co-opt and hide from our immune defences and that just saying "autoimmune" seems like a lazy deflection - so i really hope as well that this research turns up positive, but the pace, cancellations, openness and practices of the researchers leaves me suspicious.
01-04-2017, 04:53 AM   #886
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if it was shown in primates it may be interesting

It's been seen in stumptailed macaques and other primates multiple times, see the MAP description I made with links to resources you can read.

It's not about if it's "interesting". It's costing farmers millions, I talk to those people on a regular basis, the same people who test MAP in animals, have vested interest to test the presence of MAP in humans.

Cows shed MAP in their faeces, when a calf is born they get infected, it contaminates the soil and the nearby river aerosol will show the presence of MAP a few weeks later, it seeps into the soil and can contaminate other farms. In a few weeks time the whole dairy farm is infected. For the farmer it often means the end of their business. Cows with Ptb no longer produce enough milk to be economically viable and can not be sold, few nations have government programs to help recoup the cost of Ptb infections. Japan is one of the few nations where a farmer program fully recoups the cost of the lost cow if it's shown to host MAP, in the West these programs are severely lacking and the farmers ends up paying the bill.

This is reason we have government funded research going into the zoonotic potential of MAP, if MAP is making people sick then it's a worldwide public health crisis. There is no reason to be dismissive about it or to call it "hysteria".

http://www.crohnsforum.com/wiki/MAP


https://www.ncbi.nlm.nih.gov/pubmed/3559275

crohns causing disparate inflammation of all the digestive tract, joints, eyes, potential vitamin synthesis errors and more
Typical crohn's disease is transmural patchy inflammation of the ileum and sometimes colon involvement, not "all the digestive tract". We don't call disease that isn't UC but has patchy colon inflammation crohn's disease, we call it crohn's colitis to make the distinction. A name used in the past for crohn's disease and still often used is chronic enteritis, ileum involvement, not just any place.

Inflammation in CD is very specific, during early biopsies you can pinpoint the inflammation down to the peyer's patches, only found in the ileum.

I'm sure there are lots of people diagnosed with CD that don't actually have chronic enteritis, but that doesn't mean that you can paint the disease with such a wide brush and argue that inflammation is present anywhere, it's not.

I feel there's a desperation here that it isnt autoimmune but rather an infection...and is less embarrassing
Autoimmunity requires the presence of a self-antigen, which has never been conclusively found in people with CD. All genetic predispositions, ATG16L1, NOD2, even anomalies in vitamin D receptors, activity of the peyer's patches during teenage years coinciding with disease onset, all of those factors point to continued bacterial involvement. They point to innate immunodeficiences and autophagy and APC anomalies. Not to mention the actual presence of bacteria found in lesions, AIEC has been consistently recovered from CD intestinal tissue. That is why bacterial involvement is contemplated, not due to "desperation or embarassment".

I'll end the conversation there I think, not too fond of the arguments being used.

Last edited by kiny; 01-04-2017 at 05:58 AM.
01-04-2017, 11:50 AM   #887
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Anonymous 77, I understand your situation. You are a med student, talking to the specialists and I am guessing, not in the best position to argue other points of view with them. (They actually seem rather patronizing) However, I think Kiny made some excellent arguments which I hope will keep your mind open. I also hope you don't judge the validity of MAP based on one project. Once again, borrowing from the experience of TB, there are currently 15 human trials going on right now which are testing vaccines. There have been many earlier ones too. So far, not one has made it to Phase 3, but they keep trying! If the MAP vaccine works, we will all dance on the rooftops, but if it doesn't, it doesn't mean that MAP is not the culprit. It just means that the MAP vaccine, like the other vaccines against mycobacteria, will need more work. I wouldn't throw the baby out with the bath water.
01-05-2017, 08:21 AM   #888
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Im a med student near qualifying and we were taught that it was certainly autoimmune
Crohn's is not an autoimmune disease. That is an outdated theory which originated in the 1960s and was disproven a number of years ago.
01-05-2017, 12:57 PM   #889
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Sorry everyone i am away on placement so cant answer very often - ill get round to responding in a couple of days.
01-06-2017, 09:57 AM   #890
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New article:

Gut Pathog. 2017 Jan 3;9:1. doi: 10.1186/s13099-016-0151-z. eCollection 2017.
Mycobacterium avium subsp. paratuberculosis and associated risk factors for inflammatory bowel disease in Iranian patients.

Zamani S1, Zali MR2, Aghdaei HA2, Sechi LA3, Niegowska M3, Caggiu E3, Keshavarz R4, Mosavari N4, Feizabadi MM5.
Author information

  • 1Department of Microbiology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
  • 2Gastroenterology and Liver Diseases Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran ; Basic and Molecular Epidemiology of Gastrointestinal Disorders Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  • 3Department of Biomedical Sciences, University of Sassari, Viale San Pietro 43b, 07100 Sassari, Italy.
  • 4PPD Tuberculin Department, Razi Vaccine & Serum Research Institute, Karaj, Iran ; Reference Laboratory for Bovine Tuberculosis, Razi Vaccine and Serum Research Institute, Agricultural Research Education and Extension Organization (AREEO), Tehran, Iran.
  • 5Department of Microbiology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran ; Thoracic Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.


Abstract

BACKGROUND:

Inflammatory bowel disease (IBD) is described as a relapsing condition with high morbidity and uncertain complex pathogenesis. The association of Mycobacterium avium ssp. paratuberculosis (MAP) with Crohn's disease (CD) in human has been debated for decades, however there is no confirmed data to verify such relations in Iran. The aim of this study was to investigate risk factors and a possible role of MAP in Iranian patients with CD.
METHODS:

Anti-MAP antibodies were detected in serum of IBD patients and subjects without IBD (nIBD) through ELISA; MAP DNA and viable MAP cells were identified in patients' biopsies through nested PCR and direct culture methods, respectively. Principal component analysis (PCA) was used to investigate the risk factors in relation to IBD and MAP infection.
RESULTS:

Positivity for IS900 PCR was detected in 64% (n = 18) of CD, 33% (n = 10) of ulcerative colitis (UC) and 9.7% (n = 6) of nIBD samples. Live MAP cells were isolated from biopsies of 2 CD patients only. Among 28 patients with CD, 46% (n = 13) and 39% (n = 11) were positive for antibodies against MAP3865c133-141 and MAP3865c125-133 peptides, respectively, whereas much lower seroreactivity was detected in UC subjects accounting for 3% (n = 1) for MAP3865c133-141 and 16.7% (n = 5) for MAP3865c125-133. A high immune reactivity to MAP epitopes among CD patients was positively correlated with consumption of fast food meals and IBD familiarity. For both CD and UC, breastfeeding period and consumption of fruit/vegetables presented negative correlation with the presence of anti-MAP antibodies.
CONCLUSIONS:

This study provided evidences that high prevalence of MAP DNA and anti-MAP antibodies in CD patients is significantly associated with the development of CD. Despite the role of several factors contributing to IBD, the presence of MAP DNA and anti-MAP antibodies in Iranian CD patients highlights a possible transmission of MAP from animal-derived products to humans.
01-06-2017, 08:09 PM   #891
JMC
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For the benefit of Anonymous77:

http://www.tandfonline.com/doi/abs/1...nalCode=ierm20
01-06-2017, 08:32 PM   #892
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I would still very much like to know what's going on with the vaccine.

Phase I trials were supposed to start earlier this year and were delayed due to a manufacturing pickup. IŽd love to know what's the current news on this as the website hasn't been updated in a while...
On the CMV site's January 2017 Newsletter, they have a section at the bottom giving Research Update. There they say that Phase 1 will open at the end of this month and will be run by the Jenner Institute. Fingers crossed!
01-08-2017, 12:33 AM   #893
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BOut time. I hope it succeeds. I know that team has worked very hard over the years.
01-08-2017, 10:59 AM   #894
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On the CMV site's January 2017 Newsletter, they have a section at the bottom giving Research Update. There they say that Phase 1 will open at the end of this month and will be run by the Jenner Institute. Fingers crossed!
I look forward to that being independently confirmed as there is stil no mention of the CMV on the Jenner website: http://www.jenner.ac.uk/research-programmes
01-11-2017, 06:28 PM   #895
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I look forward to that being independently confirmed as there is stil no mention of the CMV on the Jenner website: http://www.jenner.ac.uk/research-programmes
The Jenner institute have now posted about this on their Facebook page: https://m.facebook.com/JennerInstitu...?locale2=en_GB
01-19-2017, 08:37 AM   #896
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Good news everyone!

Recruiting of healthy volunteers for phase 1 of MAP vaccine clinical trial has begun!

Participant information sheet here: https://s3.amazonaws.com/trialspark/...c4b05859b4.pdf

Registration form here: https://trialspark.com/trials/hav001oxford
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02-14-2017, 01:41 PM   #897
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There will be one more MAP symposium on March 24-25, 2017 in Philadelphia:

http://humanpara.org/2017-map-conference/

From my understanding, Human Paratuberculosis Fundation is new legal structure of http://TheCrohnsInfection.org

Saddened by the fact that attendance is limited to researchers only, as I understood.
02-14-2017, 05:48 PM   #898
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There will be one more MAP symposium on March 24-25, 2017 in Philadelphia:

http://humanpara.org/2017-map-conference/

From my understanding, Human Paratuberculosis Fundation is new legal structure of http://TheCrohnsInfection.org

Saddened by the fact that attendance is limited to researchers only, as I understood.
Thanks for sharing Zim! I've been so busy getting Human Para together that I haven't had time to give out any info here. Yes, there's a conference coming in a month and it is limited to researchers. But that may be good, because they are presenting their research to each other and then doing a working session where they hope to come to some type of consensus on how they will all move MAP science forward. That's REALLY good for patients, and patient participation may come at the expense of having time for collaboration on the part of the docs. I know from this collaboration that they are all still very focused on the patients needs and moving treatment applications surrounding human MAP forward for the benefit of those who are sick.

The organizers of the conference know patients are VERY interested, so they are allowing the Human Para Foundation to come and record all of the presentations and tape interviews with the researchers, which will all be put out on the site as soon as possible. They will all be freely accessible. No one will have to pay to access this content. As soon as we have more info on attendees and presentations topics, I will post that on the HPF conference page.
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Currently on: Anti-MAP therapy and loving life! Full remission since Jan 2015. Clarithromycin, rifampin and low dose naltrexone. (Levofloxicin had too many side effects so discontinued after 5 months.) Resources on human MAP and Crohn's here: HumanPara.org.

Past (failed) Treatments: Remicade, Humira, Prednisone, Pentasa, Azulfadine, Lialda, No gluten/dairy/sugar/coffee or processed food in general. Flagyl worked but not long term.
05-09-2017, 03:43 PM   #899
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Hi Irishgal,

What do you mean you have been taking an Anti-MAP therapy? Are you referring to the clinical trial in Oxford? Have they already begun phase 1 of the trial or is there still time to register?
05-09-2017, 03:53 PM   #900
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Hi Irishgal,

What do you mean you have been taking an Anti-MAP therapy? Are you referring to the clinical trial in Oxford? Have they already begun phase 1 of the trial or is there still time to register?
I believe she is taking a combination of oral antibiotics similar/the same as what is offered in the Redhill Map phase 3 trial.

The anti-map Vaccine trial in Oxford in in phase 1, which means it is being tested on healthy adults with no illnesses and no Crohn's/IBD to see if it is first safe. Phase 2 trials will begin I think in 2018, which is where the vaccine will be tested on patients with Crohn's disease to see whether it is effective at treating Crohn's.
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