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» LymeNet Flash » Questions and Discussion » Medical Questions » NIH Clinical Trial (recruiting): Minocycline for Autism

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Author Topic: NIH Clinical Trial (recruiting): Minocycline for Autism
ldfighter
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http://www.clinicaltrials.gov/ct/show/NCT00409747

"This present study will test the effectiveness of minocycline, an antibiotic with anti-inflammatory properties, in treating regressive autism. Although behavioral therapies have improved some symptoms of autism, there are no medical treatments for the disorder, and many children have ongoing behavioral difficulties. A medicine with anti-inflammatory properties may be beneficial for children with regressive autism.

This will be an open-label trial, meaning all children in this study will receive minocycline. They will also receive vitamin B6 to reduce the possible chance of side effects of the minocycline.

Children ages 3 to 12 with regressive autism may be eligible for this study. The children will take minocycline and vitamin B6 daily for 6 months. Prior to starting the medication and vitamin B6, children will receive a comprehensive diagnostic assessment for autism as well as a physical examination, medical history, and laboratory tests. Children will then receive ongoing assessments to monitor their behavior, communication, language skills, and medical issues at 2 weeks, and at 1, 2, 4, 6, and 12 months. Children who respond to the treatment will receive an additional 3 months of minocycline and vitamin B6..."

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bettyg
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please copy this to general as well; there's a mom there of either 2 or 3 of 3 kids with AUTISM; big thanks! [Wink]
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ldfighter
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Done, thanks Betty!
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Looking
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Thanks so much for posting this ldfighter. I'm very interested to see if pathogen load is a major contributing factor in autism.

I'm looking forward to reading about the results of this study.

Looking

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ddel
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Unlocking the autism disorder would be a significant breathrough not only for medical science but for humankind and society. I have dedicated years of working wtih autistic children and have always questiones causation. My belief thus far is mercury in vaccines and diet. This will be an interesting study to watch. Autism is a relatively new disorder in persective, as is lyme disease. ---- something to ponder.
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ldfighter
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up
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catalysT
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Nice idea, but I suspect the results will not be promising. They probably wont use probiotics or proper diets or anything. Most of the time it will probably end up resulting with exhaberation of fungal infections. Antibiotics without probiotics is harmful.

They'd need to at least use minocycline with fluconazole or something. So unfortunately the headline will probably read "Minocycline is not an effective treatment for autism".

Just my 2 cents.

--------------------
"You know, the worst, meanest, nastiest, ticks in the world are politicks," - Steve Nostrum

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Keebler
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-


1. VERY good point above about protection for fungal infections.

True, as stated, if there is failure of the trial, that the failure may not be identified correctly due to lack of protective measures against candida, etc. but also against abx GI irritation and leaky-gut (with L-glutamine?).

2. Another thought is that if lyme is present, the single abx could cause lyme to go into the cyst form. If that is not addressed it could cause problems down the road. If lyme is present, is minocycline enough to address all forms?

3. If lyme is present and this kids herx, who will be handling the treatment for that - for getting out the toxins? And liver support / protection?

4. from the link for the study these kids have to have a spinal tap. It that really necessary? That's really hard on a kid.

"Willingness to undergo lumbar puncture for evaluation of proinflammatory CSF cytokines."


5. Minocycline can be ototoxic. Vertigo is likely.

(EDIT to add- They seem to have figured this in with additon of B6. See abstract 2 threads down).


I'm all for addressing possible infection as a basis for autism, however, I have serious reservations about the drug chosen unless protective measures are employed - and lyme researchers can be part of the study.

===

from a Professor, Pharmacology
at University of Michigan Medical School (details at link)

http://tinyurl.com/2tewss

Ototoxic Drugs: The Drugs - excerpt:

Minocycline (MINOCIN) appears to be the only member of its class (the tetracyclines, which are widely used antibiotics) to cause ototoxicity.

It's of the vestibular toxicity type. Apparently signs and symptoms (see above) can develop after only one or two doses. They usually disappear a day or two after the drug is stopped.

. . . .
(Edit to add: with B6 info., this might be adverted)
-

[ 18. November 2007, 04:43 PM: Message edited by: Keebler ]

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Keebler
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-

PubMed Search - www.ncbi.nlm.nih.gov/sites/entrez

minocycline, children- 227 abstracts
minocycline, liver - 138
minocycline, lupus - 87
minocycline, lyme - 26

my thought on some of the reactions noted in abstracts below is that they may have been actual lyme flairs or herx reactions.

If such reactions happen in a study with autistic kids - and some reactions are likely to happen - will the researchers know how to distinguish such possible reactions? What if 8.5 percent develop lupus-like or mono-like reactions? Will lyme researchers be part of this study so that all reactions properly identified for the underlying causes ?

=============================

http://tinyurl.com/yo7nth

Schweiz Rundsch Med Prax. 2006 Aug 30;95(35):1297-303.Links

[Minocycline-induced lupus erythematodes]
[Article in German]

excerpt: In the Swissmedic and WHO adverse drug reaction databases 267 other cases of possible minocycline-induced lupus were identified.
====================

http://tinyurl.com/ytagev

J Cutan Med Surg. 2006 May-Jun;10(3):131-5.Links

Drug hypersensitivity syndrome caused by minocycline.

Department of Dermatology, Osaka City University Graduate School of Medicine, Osaka, Japan. [email protected]

Excerpt: Minocycline is able to elicit a drug hypersensitivity syndrome that can resemble infectious mononucleosis.

============================

http://tinyurl.com/2ylusj

: Ann Med Interne (Paris). 1998 Dec;149(8):521-3.Links

[Immunoallergic reaction with hepatitis induced by minocycline]
[Article in French]

Service de M�decine Interne, CHU Michallon, Grenoble.

Excerpt:

Several cases of induced lupus, autoimmune hepatitis, eosinophilic pneumonia, hypersensitivity syndrome, serum-sickness-like illness and Sweet's syndrome have already been described. These side effects are rare but may be life-threatening.

================================

http://tinyurl.com/2bghtq

J Rheumatol. 2001 May;28(5):1004-6.

Minocycline induced lupus: case series in the West of Scotland.
Centre for Rheumatic Diseases, Glasgow Royal Infirmary and Gartnavel General Hospital, Scotland.

Excerpt:

Although the absolute risk of developing drug-induced lupus is relatively low, it has been estimated that current use of minocycline is associated with an 8.5 fold increased risk of developing a lupus-like syndrome.

===========

[ 18. November 2007, 04:57 PM: Message edited by: Keebler ]

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Keebler
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-

B6 remarkably reduced vestibular symptoms w/ mino - the abstract will have related links to the right at the web site.

This is from 1988 - I can't believe I've not come across this in my hunt to be able to tolerate minocycline due to vertigo. Protection from ototoxicity with mino would require more research but this abstract looks good:

excerpt:

However, when combining minocycline with vitamin B 6, the vertigo and nausea symptoms as well as the nystagmus signs from the monaural and the binaural vestibular ocular tests as well as the vestibular spinal signs from the craniocorpography recordings of the stepping and the standing procedures were remarkably reduced.

==================================

http://tinyurl.com/2kkrp7

Arzneimittelforschung. 1988 Mar;38(3):396-9.Links

[Antivertiginous action of vitamin B 6 on experimental minocycline-induced vertigo in man] [Article in German]

Claussen CF, Claussen E.

Neurootologie, Universit�ts-HNO-Klinik W�rzburg.

By means of a former investigation it has been proved equilibriometrically that the application of 7 X 100 mg minocycline may induce a central equilibrium dysregulation of the brainstem type.

It was the purpose of this study to further assure that the minocycline induced brainstem vertigo is due to a destabilization of a supervisory gamma-aminobutyric acid (GABA)ergic loop from the archeocerebellum upon the pontomedullary vestibular regulating pathways.


As it is pharmacologically known that pyridoxine is essential for the synthesis of GABA, an inhibitory CNS neurotransmitter, 2 separate double blind trials on 20 healthy young persons each were carried out after the intake of 7 X 100 mg minocycline during 3 days with and without 7 X 40 mg pyridoxine simultaneously.


These trials were checked against an additional placebo or initial non drug investigation. In all the 40 test persons it could be proved that the amount of vertigo and nausea symptoms was increased significantly due to the application of minocycline only.


However, when combining minocycline with vitamin B 6, the vertigo and nausea symptoms as well as the nystagmus signs from the monaural and the binaural vestibular ocular tests as well as the vestibular spinal signs from the craniocorpography recordings of the stepping and the standing procedures were remarkably reduced.


There were no statistical differences between the initial or placebo trials versus the trials with a combination of minocycline with vitamin B 6.

The same holds for the vestibular vegetative reactions, measured by the simultaneous electrocardiography during the vestibular tests.

All the equilibriometric tests applied showed a significant destabilization under the influence of a pure minocycline loading. (ABSTRACT TRUNCATED AT 250 WORDS)

PMID: 3382463 [PubMed - indexed for MEDLINE]

-

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bejoy
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Dr. K. has noted that he believes first born children with autism are generally responding to a heavy metal load from the mother. Second and additional children with autism often have lyme.

It seems that yeast in both cases tends to play an important role, since the body tends to grow prolific yeast when there is a high mercury load. Somehow mercury and heavy lyme symptomatology are connected.

I am concerned about treatment with B6. I have read and experienced that B6 on it's own can cause serious and sometimes permanent nerve damage. According to what I have read, B6 should always be taken with a B complex.

--------------------
bejoy!

"Do not go where the path may lead; go instead where there is no path and leave a trail." -Ralph Waldo Emerson

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Keebler
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Bejoy - Thanks for that info. I had forgotten about that.

I hope, in the study to be done, that the dose of B6 will be balanced properly with the other B's.

-

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