Hi all, this looked very current and although it's being called a celiac drug, when I read the article they were talking about preventing leaky gut. Then they had my attention!
http://www.celiac.com/articles/23718/1/ ... Page1.html
Have a good weekend,
Carol
Ongoing trials of a med to prevent leaky gut--
Moderators: Rosie, Stanz, Jean, CAMary, moremuscle, JFR, Dee, xet, Peggy, Matthew, Gabes-Apg, grannyh, Gloria, Mars, starfire, Polly, Joefnh
Ongoing trials of a med to prevent leaky gut--
“.... people will forget what you said, people will forget what you did, but people will never forget how you made them feel.” Maya Angelou
Carol,
I only read the article far enough to see that it is about larazotide acetate, and then skimmed the rest. Larazotide acetate is the anti-zonulin drug that Dr. Fasano and his group at the University of Maryland School of Medicine developed before they sold out to a private company for zillions of dollars for an unproven drug. All of which we've discussed previously. I haven't heard any more about it until I saw your post.
Those trials have been going on for a long time — so long that it's pretty obvious that they have encountered unanticipated obstacles. (I say this because the drug was originally claimed to be a candidate for fast-track FDA approval — obviously that hasn't happened.) My guess is that Dr. Fasano could see the "hidden" problems, and that's why he sold out when he did (when it appeared to be slated for fast-track approval). But as far as I'm aware, they are still trying to get it approved by the FDA.
My personal opinion is that like most drugs, it will help, and it may even be able to prevent clinical symptoms in many/most cases, but it will not stop the inflammation from continuing. All it will do is to minimize the tendency of the tight junctions to open when the immune system detects gluten. That should prevent most clinical symptoms, but the problem is that the anti-gliadin antibodies (and autoantibodies) will continue to be produced, and that can't be good, because it will leave the door open for the development of additional AI diseases.
And sadly, they will not have to disclose the fact that the drug will not stop antibody production in their application to the FDA for approval (in classic "what the consumers don't know won't hurt them" style that's always in vogue at the FDA
). I'm sure that if they can successfully get FDA approval (and I'm guessing that they will), it will sell like hotcakes to celiacs who are still in love with gluten.
Did you notice the 2 responses that were posted? They are both right. The first one is right on target regarding the health benefits of the drug, and the second one validates my observation that it will surely sell like hotcakes.
Tex
I only read the article far enough to see that it is about larazotide acetate, and then skimmed the rest. Larazotide acetate is the anti-zonulin drug that Dr. Fasano and his group at the University of Maryland School of Medicine developed before they sold out to a private company for zillions of dollars for an unproven drug. All of which we've discussed previously. I haven't heard any more about it until I saw your post.
Those trials have been going on for a long time — so long that it's pretty obvious that they have encountered unanticipated obstacles. (I say this because the drug was originally claimed to be a candidate for fast-track FDA approval — obviously that hasn't happened.) My guess is that Dr. Fasano could see the "hidden" problems, and that's why he sold out when he did (when it appeared to be slated for fast-track approval). But as far as I'm aware, they are still trying to get it approved by the FDA.
My personal opinion is that like most drugs, it will help, and it may even be able to prevent clinical symptoms in many/most cases, but it will not stop the inflammation from continuing. All it will do is to minimize the tendency of the tight junctions to open when the immune system detects gluten. That should prevent most clinical symptoms, but the problem is that the anti-gliadin antibodies (and autoantibodies) will continue to be produced, and that can't be good, because it will leave the door open for the development of additional AI diseases.
And sadly, they will not have to disclose the fact that the drug will not stop antibody production in their application to the FDA for approval (in classic "what the consumers don't know won't hurt them" style that's always in vogue at the FDA
). I'm sure that if they can successfully get FDA approval (and I'm guessing that they will), it will sell like hotcakes to celiacs who are still in love with gluten.Did you notice the 2 responses that were posted? They are both right. The first one is right on target regarding the health benefits of the drug, and the second one validates my observation that it will surely sell like hotcakes.
A waste of research time and money. We need a better solution than this band aid. Put the money to a more specific solution of counteracting the reaction to gluten in the intestine.
Thanks, and I hope that you have a most enjoyable weekend also.Does anyone know when larazotide acetate will be available for consumer use?
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
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Tex,
My knee jerk reaction to most research reports is to figure something isn't right here, even if I don't know what exactly it is about the report that signals it's less than it is being made out to be. You then provide me with the reason for doubting it and I thank you for that. I can continue to be a skeptic without doing any of the hard work to back up my skepticism.
Jean
My knee jerk reaction to most research reports is to figure something isn't right here, even if I don't know what exactly it is about the report that signals it's less than it is being made out to be. You then provide me with the reason for doubting it and I thank you for that. I can continue to be a skeptic without doing any of the hard work to back up my skepticism.
Jean
Thanks Tex, I wondered if it was ongoing or was even old info, then I couldn't get into Medscape, and frankly didn't have time to do a broader search. I see what you are saying about how the inflammation will continue, even if the joints don't open.
Yesterday I read an impressive article about the occurrence of mast cells disorders in children with autism. We already knew that kids with autism have higher rates of digestive issues relative to other kids their age, 10 times more likely in fact. This study discussed how inflammation (and elements leading to inflammation) cross the blood-brain barrier, setting up the child for inflammation all over, particularly the brain which would be vulnerable in the early developmental stages. I was riveted at the implication. I may post it here sometime if you don't mind. It's by Dr. Theo Theoharides, et al.
take care,
Carol
Yesterday I read an impressive article about the occurrence of mast cells disorders in children with autism. We already knew that kids with autism have higher rates of digestive issues relative to other kids their age, 10 times more likely in fact. This study discussed how inflammation (and elements leading to inflammation) cross the blood-brain barrier, setting up the child for inflammation all over, particularly the brain which would be vulnerable in the early developmental stages. I was riveted at the implication. I may post it here sometime if you don't mind. It's by Dr. Theo Theoharides, et al.
take care,
Carol
“.... people will forget what you said, people will forget what you did, but people will never forget how you made them feel.” Maya Angelou
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Gabes-Apg
- Emperor Penguin
- Posts: 8332
- Joined: Mon Dec 21, 2009 3:12 pm
- Location: Hunter Valley NSW Australia
Carol,
When tested, 60-70% of children with autism are found to have Pyrrole gene mutation active.
Pyrrole means the body can not clear heavy metal properly, the cells are deficient in various nutrients imperative for a few hundred actions in the body.
The current meds help, but do not resolve.
The medical practice I now attend, this is one of their key focus. 2 of the doctors only treat children, most with autism, ADHD.
Treatment?? Gluten and dairy free diet, low in preservatives and processed ingredients, bone broth to fix leaky gut, supplement protocol to fix deficiencies and keep inflammation minimised.
When tested, 60-70% of children with autism are found to have Pyrrole gene mutation active.
Pyrrole means the body can not clear heavy metal properly, the cells are deficient in various nutrients imperative for a few hundred actions in the body.
The current meds help, but do not resolve.
The medical practice I now attend, this is one of their key focus. 2 of the doctors only treat children, most with autism, ADHD.
Treatment?? Gluten and dairy free diet, low in preservatives and processed ingredients, bone broth to fix leaky gut, supplement protocol to fix deficiencies and keep inflammation minimised.
Gabes Ryan
"Anything that contradicts experience and logic should be abandoned"
Dalai Lama
"Anything that contradicts experience and logic should be abandoned"
Dalai Lama
Carol,
Sure, it never hurts us to learn something new. Speaking of childhood dietary issues, have you seen the following research article, where researchers found that 72 % of adolescents with psychotic issues, had either deficient or insufficient vitamin D blood levels?
I pulled that one out of the book I'm working on about vitamin D. I didn't discuss autism in the book (since that's not the focus of the book — it's about the development of AI issues), but autism has vitamin D deficiency links also, and it's almost surely connected with the CNS inflammation issue that you mentioned (since the VDRs control many/most of the genes associated with the expression of inflammation mediators. Maybe that could be explored in depth in a future book.
Thanks,
Tex
Sure, it never hurts us to learn something new. Speaking of childhood dietary issues, have you seen the following research article, where researchers found that 72 % of adolescents with psychotic issues, had either deficient or insufficient vitamin D blood levels?
Gracious, B. L., Finucane, T. L., Friedman-Campbell, M., Messing, S., & Parkhurst, M. N. (2012). Vitamin D deficiency and psychotic features in mentally ill adolescents: A cross-sectional study. BioMed Central Psychiatry, 12(38). Retrieved from http://www.biomedcentral.com/1471-244X/12/38Results
Vitamin D deficiency (25-OH D levels <20 ng/ml) was present in 34%; vitamin D insufficiency (25-OH D levels 20–30 ng/ml) was present in 38%, with a remaining 28% in the normal range. Adolescents with psychotic features had lower vitamin D levels (20.4 ng/ml vs. 24.7 ng/ml; p = 0.04, 1 df). The association for vitamin D deficiency and psychotic features was substantial (OR 3.5; 95% CI 1.4-8.9; p <0.009). Race was independently associated with vitamin D deficiency and independently associated with psychosis for those who were Asian or biracial vs. white (OR = 3.8; 95% CI 1.1‒13.4; p < 0.04). Race was no longer associated with psychosis when the results were adjusted for vitamin D level.
I pulled that one out of the book I'm working on about vitamin D. I didn't discuss autism in the book (since that's not the focus of the book — it's about the development of AI issues), but autism has vitamin D deficiency links also, and it's almost surely connected with the CNS inflammation issue that you mentioned (since the VDRs control many/most of the genes associated with the expression of inflammation mediators. Maybe that could be explored in depth in a future book.
Thanks,
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Tex, wow, I hadn't read that study. This is really exciting to find these deficiencies that should be relatively easy to rectify. It's certainly preferable to high powered psychotropic meds, which is likely to be what kids will get when they see the local psychiatrist. I look forward to reading it.
Gabes, I had also read that processing metals was problematic for kids with ASD. I work with a young man (age 10) who constantly has dark circles under his eyes, had obvious allergy symptoms and will go days without sleeping. When I was reading about mast cells he was definitely on my mind. There are times this guy is absolutely miserable. I'm glad you mentioned pyrrole. I'll look into that.
His parents have pulled out all the stops to help him but seem to have hit a brick wall on the allergies and sleep issues. Maybe a vitamin D level and exploration of mast cell or pyrrole is in order.
thank you both-- so much research and so little time to get it all read!
Carol
Gabes, I had also read that processing metals was problematic for kids with ASD. I work with a young man (age 10) who constantly has dark circles under his eyes, had obvious allergy symptoms and will go days without sleeping. When I was reading about mast cells he was definitely on my mind. There are times this guy is absolutely miserable. I'm glad you mentioned pyrrole. I'll look into that.
His parents have pulled out all the stops to help him but seem to have hit a brick wall on the allergies and sleep issues. Maybe a vitamin D level and exploration of mast cell or pyrrole is in order.
thank you both-- so much research and so little time to get it all read!
Carol
“.... people will forget what you said, people will forget what you did, but people will never forget how you made them feel.” Maya Angelou
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Gabes-Apg
- Emperor Penguin
- Posts: 8332
- Joined: Mon Dec 21, 2009 3:12 pm
- Location: Hunter Valley NSW Australia
Carol, given the symptoms mentioned, high probability.
Vit D3,
Magnesium and Vit C, for gut /mast cell, immune system/adrenals, clearing heavy metals
Zinc, mainly to clear metals, also for gut etc
Pyrrole specific supps, meth form of B12, P5P, B6, molybdenum, Vit E.
Gluten and dairy free diet is just as important as the supps.
Of note, based on the recent discussions about Vit D, vitamin d receptors etc. cell health and effectiveness of Vit d3 will keep deteriorating if there are other deficiencies like the mag, Vit C and zinc etc.
Vit D3 alone is not enough.
Vit D3,
Magnesium and Vit C, for gut /mast cell, immune system/adrenals, clearing heavy metals
Zinc, mainly to clear metals, also for gut etc
Pyrrole specific supps, meth form of B12, P5P, B6, molybdenum, Vit E.
Gluten and dairy free diet is just as important as the supps.
Of note, based on the recent discussions about Vit D, vitamin d receptors etc. cell health and effectiveness of Vit d3 will keep deteriorating if there are other deficiencies like the mag, Vit C and zinc etc.
Vit D3 alone is not enough.
Gabes Ryan
"Anything that contradicts experience and logic should be abandoned"
Dalai Lama
"Anything that contradicts experience and logic should be abandoned"
Dalai Lama