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12-15-2014, 06:01 PM   #1
VilliVagabond
 
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RHB 104 - Clinical Trial Documentary

All,

I recently was approved to move forward with the RHB-104 clinical trial. I know that there has been a tremendous amount of speculation as to whether or not this will prove to be an effective solution, so I thought I would document my progress as I move through the trial.

What you can expect from me:

1.) Weekly updates, on Sunday evening, EST. I will provide an overview of the weeks symptoms, drug related interactions, and a general status update.
2.) Overview of dosage
3.) Any findings or updates from doctors

Keeping in mind that every participant in this trial has a 50 / 50 shot of getting the placebo (and I currently do not own a mass spectrometer, so can't tell you for sure whether or not I have the real drug)...I don't know if this is even going to prove effective.

I would ask that you don't PM me with questions - I maintain a day job and am very busy keeping up with both it and my Crohn's. I will try and answer all questions between posts as they come.

Thanks!

Villi
12-15-2014, 10:16 PM   #2
rollinstone
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Good luck, fingers crossed you get the drug n not placebo. Look forward to hearing updates.
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-Are you looking for a new treatment option for your Crohn's disease? If so, I suggest you look into the ongoing clinical trial by Qu Biologics for their SSI treatment. Click here for more information or to help spread the word.
12-17-2014, 02:47 AM   #3
Malgrave
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Thanks a lot Villi!
My son is on Rifabutin and it makes his pee very red. I wonder if that will happen also to patients with RHB-104. That would tell you that you are getting the real medicine instead of placebo....
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*Son (9 years) with severe Crohn's diagnosed at the age of 26 months, currently UC or Crohn's colitis
*Current mediacation: IVIG, Humira, Azathpriorine, Eusaprim
(Tested but failed: Modulen IBD, Neocate advance, Budenofalk, Remicade, Azathpriorine, MTX, Jerusalem cocktail, cycklosporine, pentasa,...)
12-17-2014, 04:30 AM   #4
SarahD
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Thanks Villi, I'm definitely interested to hear how you get on. Good luck and I look forward to your updates!
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Symptoms from the age of 12. Mis-diagnosed with UC at the age of 13, and later diagnosed with Crohn's in January 2012 at 24 years old. Disease mainly in terminal ileum.


Current meds:
Azathioprine, Allopurinol, Calcichew D3-Forte, Fortijuice, Alendronic acid, Ranitidine

Previous meds:
Augmentin, Doxycycline, Lansoprazole, Asacol, Pentasa, Prednisolone, Entocort, Cipro, Flagyl, Elemental Extra 028
12-17-2014, 10:41 AM   #5
Tesscorm
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Thanks for sharing your experiences during the trial. I hope you see positive results!
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Tess, mom to S, 22
Diagnosed May 2011

Treatment:
May-July 2011 - 6 wks Exclusive EN via NG tube - 2000 ml/night, 1 wk IV Flagyl
July 2011-July 2013 - Supplemental EN via NG, 1000 ml/night, 5 nites/wk, Nexium, 40 mg
Feb. 2013-present - Remicade, 5 mg/kg every 6 wks
Supplements: 1-2 Boost shakes, D3 - 2000 IUs, Krill Oil
12-18-2014, 01:31 AM   #6
HelenMelb
 
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Best of luck! Thanks for posting and wishing you great results.
12-21-2014, 05:46 PM   #7
MamaHenn
 
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Good luck and thank you for sharing.
12-23-2014, 12:33 PM   #8
VilliVagabond
 
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Hey y'all,

Sorry I missed the Sunday update. Very busy.

1.) Slight improvement since starting the regimen. The trial has people taper "up" (weird, I know, for those of us familiar with prednisone) but you take 1 pill 2x a day for the first week, 2 pills 2x a day for the second, etc. etc....until you reach 5 pills 2x a day in the 5th week.

2.) Side effects - the only side effect I have been having is some night sweats. They aren't terrible, but yesterday, I woke up at 3:45 a.m. with "OMG I've been in a desert for 3 days and there is an Oasis right in front of me so I'm gonna drink the entire lake" type of thirst.

3.) I'll be back after the holidays!
12-23-2014, 01:49 PM   #9
Crohn2357
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I had night sweats with clarithromycin.
12-23-2014, 02:46 PM   #10
worriedboy
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I have been waiting for someone who is taking part at the RHB104 trial for a long time now. Really glad you are here to let us know how it goes !

I wish you best of luck and hopefully the combo will do the trick for you.

Could you tell where is you disease located ?
And have you had any MAP test done ?
12-31-2014, 03:50 AM   #11
Rblock06
 
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Have you figured out if your on the the real meds yet or the placebo. Your urine should definitely be orange if your on the real meds.
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12-31-2014, 11:46 AM   #12
rollinstone
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Have you figured out if your on the the real meds yet or the placebo. Your urine should definitely be orange if your on the real meds.
Just curious as towards your signature, you are on anti map & humira?!
12-31-2014, 02:06 PM   #13
Rblock06
 
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I've been on the anti-map awhile now, I was scoped after being on it for six months and still had a lot of inflammation and strictures so I started back on the Humira with the anti-map. I may not have gave the antibiotics alone enough time but I didn't want to risk it.
Here is a quote from a recent article

MAP has been shown to be associated with increased levels of TNF-α – more than other types of mycobacteria and that it thrives on high levels, as shown by Bach et al. [7]. TNF-α induces apoptosis of MAP infected cells and so drugs, such as infliximab, act as an antibiotic as well as an anti-inflammatory agent. Apoptosis is induced in MAP-infected macrophages, that secrete higher amounts of TNF-α on their surface and so the survival of the white cell is reduced along with the intracellular organism. In addition, it reduces the antibody titers of two mycobacterial proteins associated with MAP [7]. The authors propose that the combination of infliximab and anti-MAP antibiotics is likely to be synergistic in healing CD lesions and have noted this in their clinical practice to date.

http://www.futuremedicine.com/doi/fu...2217/fmb.14.52
12-31-2014, 06:16 PM   #14
rollinstone
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How were your symptoms after 6 months, Borody told me it can take a while, I the think adding the humira is a smart move though, that should kick its ass back into remission. Can I ask, are getting this treatment plan from the one specialist?
12-31-2014, 07:47 PM   #15
VilliVagabond
 
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Rblock - so the anti MAP therapy didn't work for you? I only ask that because my main goal is to stay OFF Humira / Remicade...I was hoping that this would be the route to that.

Referencing your earlier comment - the placebo has a mineral in it that makes your pee turn orange so you cannot tell the difference.
12-31-2014, 08:16 PM   #16
Rblock06
 
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I wouldn't say it didn't work, as I was still not having any major symptoms. I was only having some slight abdominal discomfort. The scope wasn't good so I felt better adding the humira for awhile. I do not have any side effets from the anti map therapy or the humira. I am being treated by Dr Chamberlin
01-21-2015, 10:45 AM   #17
millan983
 
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Hello,

Can anyone here on only RHB-104 please provide the updates on the treatment and its effectiveness?

-Millan
01-26-2015, 12:09 PM   #18
wellen1981
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One thing I'm interested to know and i fear may never find out is how much diet plays a role in aiding the success of being on anti-MAP.

I altered my diet drastically (mainly just white rice and only milk in tea but lacto-free milk) and take no meds (no crohn's meds and no pain meds) and managed to get the pain down to hardly happening and even when it does happen it is bareable compared to very severe for the past 2 years (everyday) before I did my research and changed my diet.

I hope myself to get onto anti-MAP treatment in the UK by my local GP / hosptial GI following Prof Herman-Taylors advice on how to carry out the treatment.

If I do manage to be on the treatment plan I will be doing it under the strict regime of just eating rice (unless given a proven reason why it is a bad idea during the treatment) as the last thing i would want to do is to be eating the known bad foods that increase crohn's symptoms.

As another poster above mentioned I would also wonder if VilliV is in fact on the placebo as that would be such a shame if they are as the insight VilliV gives in this thread would be for nothing.

Hope you are on the real stuff VilliV
02-01-2015, 10:51 AM   #19
Mattie
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Are you able to post an update Villi?
05-24-2015, 05:40 AM   #20
rollinstone
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Any updates?
10-28-2015, 09:49 AM   #21
perfectjelly
 
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updates?
10-28-2015, 04:39 PM   #22
sir.clausin
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Weekly updates...and the post is from last winter...great
10-28-2015, 06:03 PM   #23
rollinstone
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Maybe they're feeling so good they got on with life, fingers crossed anyway
09-29-2016, 12:17 PM   #24
lmotsie
 
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Hi Guys, I know this is an old thread, but thought I'd post anyway. I am in the Phase 3 trial for rhb-104. I am in my 6th week of the meds. What I know so far:
1) I did get the real med. How do I know? Prior to the start of the meds I had a colonoscopy and blood panels drawn. I have stayed on Pentasa, which I have taken for 3 years. I am not on any biologic meds. My C reactive Protein level was at 430...way high, but standard for me for the last 2 years. I have been as high as 500. After 4 weeks on the meds my c reactive protein level has gone down to 134. My white blood cell count has dropped. Being that I have had no changes whatsoever in my other meds or supplements or diet, there could be no other explanation for the dramatic change in the protein levels.

2) There are some nasty side effects. Not saying they are not worth it if this is a cure, or at lease something to put me in remission for a long time, but they are there. The nausea, diarrhea, night sweats, gas and stomach pain from the onset of the first dose and at each increased dose was awful. lt would last 2 to 5 days from the first dose and subsequent increase in dose. A lot like having a bad flare. And no, it did not get easier as the dose increased. I am now at the full dose and have been for a week.

3) Red urine. Everyone is sure that if you get the red/orange urine then you are on the real med. Not true. They put a dye in the placebo to replicate this. Lets face it, us long term Crohnies know our antibiotics and what they do. It would be a dead giveaway for a double blind study. And my urine is RED. Not orange, not reddish...RED.

3) Inflammation markers. I have had the red palms associated with inflammation for the last 2 years.Bright red, all over the pads below my thumbs and little fingers, with other spots of redness on the palms directly under each finger. The redness has subsided greatly over the last 2 weeks. almost gone except for the pads on the lower part of my palms, under the little finger. Since that is where the redness initially started, I am not surprised that it is the last to go.


So far I am very, very hopeful that rhb-104 will be a significant help, if not a cure for crohns.
10-01-2016, 07:48 AM   #25
Zim
 
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Side effects may be caused by nocebo effect and by chemicals intentionally put into placebo to simulate side effects like nausea, night sweats and more. It would be naive to think that study designers and FDA requirements keep only colored urine in mind.

Despite that we highly hope this drug will be the last one you need before acheaving so called "life-long remission"!
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10-02-2016, 05:04 PM   #26
lmotsie
 
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I actually asked my researcher about that. She said that yes, they could replicate some of the side effects, but in doing so I would most likely feel them the same, everyday. That is not the case for me.
10-03-2016, 07:22 PM   #27
Julia S
 
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Aren´t these trials also meant to find out what the most common side effects of a drug are? If they put too many side-effect causing chemicals in the placebo, wouldn´t it be harder to do that final placebo vs active arm side-effect comparison?
10-05-2016, 12:58 PM   #28
lmotsie
 
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That is my understanding. My researcher told me that only a few in the trial are reporting the nausea, cramping, diarrhea, etc. We all are reporting the red urine.
10-05-2016, 05:05 PM   #29
Julia S
 
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Imotsie, I hope you don´t mind me asking, but where is your disease located?
10-05-2016, 08:58 PM   #30
lmotsie
 
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small intestine and upper large intestines. Many ulcers in upper intestine..mostly healed now. Stricture in lower intestine as well. Inflammation in large intestine, hiatal hernia as well.

Last edited by lmotsie; 10-05-2016 at 10:51 PM.
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