Some of you already know that we participated in the an Ultrase enzyme study, well as I ran across this article it reminded me that I needed to thank all the subjects that participated in the Creon study... So thanks guys, cuz we like our enzymes :)
Full Story
http://www.drugs.com/clinical_trials/creon-pancrelipase-delayed-release-capsules-improves-absorption-fat-young-children-cystic-fibrosis-8241.html
Showing posts with label CF Ultrase MT12. Show all posts
Showing posts with label CF Ultrase MT12. Show all posts
Friday, October 23, 2009
Thursday, October 1, 2009
We survived half of our study barely...
Trials.... hmm I think there is more meaning to this then we realize... Like this trial really TRIED my patience and sanity..... I really thought this trial would be a piece of cake... wrong... so you have to list everything you eat and drink, and keep all the packaging for 10 days ( pretty easy right) then you list the enzymes you took along with the food (no problem) and you collect all your product for five days (yes gross but no biggie) and you consume exactly 70grams of fat each day (piece of cake)... Okay no problem.. See my little CFer eats everything so making sure he consumes 70 grams of fat is so easy, actually the hardest part I think will be making sure doesn't go over... I could not be MORE WRONG.....
My little CFer, had some life changing event take place in his little life unknown to me and the past few weeks he decided he didn't want to eat anymore and actually lost like a 1.5 lbs (yep lost weight).... This was terrible, I actually made him cry, trying to convince him to eat which made me feel like cruella de'ville and I don't want him to ever feel like that... (this is actually a study for FDA approval of Ultrase, Lane currently takes creon , so to correct my wording it is a study not a trial.....) But obviously it is important with any study to do it exactly as required, so getting the food down the hatch as needed was crucial, and adding to the stress was the fact that SOME local fast food restaurants offered nutritional facts about their food and some didn't... ( eating out was a must because of the high fat, it is what saved me, I found one menu item that had 43g, sick I know ) Anyway this study, I thought would be sooooo easy... and yes we have survived to the halfway mark, YEA and I do feel that I can accomplish the second half of the study, but boy I have a totally new perspective for people who do studies and trials.. Just when you think it will be a piece of cake, bham your out of flour... :) Now the fun begins, I have to try and duplicate day for day what I did last time, food for food, amount for amount... Now he will probably be starving... What a boy will do for a trip to Chuck e Cheese... lol
My little CFer, had some life changing event take place in his little life unknown to me and the past few weeks he decided he didn't want to eat anymore and actually lost like a 1.5 lbs (yep lost weight).... This was terrible, I actually made him cry, trying to convince him to eat which made me feel like cruella de'ville and I don't want him to ever feel like that... (this is actually a study for FDA approval of Ultrase, Lane currently takes creon , so to correct my wording it is a study not a trial.....) But obviously it is important with any study to do it exactly as required, so getting the food down the hatch as needed was crucial, and adding to the stress was the fact that SOME local fast food restaurants offered nutritional facts about their food and some didn't... ( eating out was a must because of the high fat, it is what saved me, I found one menu item that had 43g, sick I know ) Anyway this study, I thought would be sooooo easy... and yes we have survived to the halfway mark, YEA and I do feel that I can accomplish the second half of the study, but boy I have a totally new perspective for people who do studies and trials.. Just when you think it will be a piece of cake, bham your out of flour... :) Now the fun begins, I have to try and duplicate day for day what I did last time, food for food, amount for amount... Now he will probably be starving... What a boy will do for a trip to Chuck e Cheese... lol
Wednesday, August 5, 2009
Update on Dr. Appt...
Morning Meds, 2 nebs treatments and vest therapy and we actually made it out of the house by 7:30am to head to OKC for our Dr. Appointment... Thirty minutes into the drive he is already taking a nap! :) 
First things first, we must weigh in... Wow, we (okay he) gained 4lbs.... we have been trying to gain weight for 6 months without gaining 1 single pound and we just made up for it.... 
Here is the proof!!! 46lbs...
We get our blood pressure..
Lane then does his Pulse oximetry . He is always amused his finger is red... 
Brother Nick, does his sweat test (he was the last one to be tested) and his results were negative for CF... So all three older kids are CF free amen... 
Lane then did his pulmonary function test (PFT)... Scored .83 of the predicted 1.06 (not really sure if I just noted that correctly still learning).... We are counting on the score raising since Lane has only performed the test on two different occasions and they need a little practice :)
This is the swab culture that Lane had done... This picture does not look so bad, but believe me he was GAGGING...... This is to test for Pseudomonas....
This was the highlight for Lane.... He waited for this moment all week.... its ME... Yes Lane could not wait until mom had her poke... We are trying to determine on which side of the family the delta f508 gene is on, so it can easily narrow down testing for family members wanting to do gene testing to determine if they are a carrier or not... so this one is for you Lane... Love ya...
Now it was time to enjoy the rest of the day with a treat. We ate some pizza and played some games... I have been trying to attach something fun with each visit... Hopefully always making good memories one visit at a time....
And look, shortly after starting home Lane is out again.... wearing the well earned stickers across his shirt....
Made it back home 10 hours later and started treatments all over again... Exhausted...
We accepted the offer to join 40 other subjects from approximately 16 study sites in the US and Canada in a study for (PERT) Pancreatic Enzyme Replacement Therapy. Pert has contributed to a significant increase in the life span of CF patients. This study is for Ultrase MT12. In the past FDA did not require the approval of these drugs, however starting in April 2010 the FDA will be regulating and requiring approval of the safety and effectiveness of these enzymes. Lane is currently using Creon 10 and will continue to for the first half of the study and then switch to the Ultrase for the second half.... The study seems to require allot of information, but will only take place over the span of 38 days. So we are going to give it a try, knowing it will benefit the many CF patients that use the drug. Although we do not currently take Ultrase, I still feel we can benefit from participating as well. Hopefully we will discover which enzyme works best for Lane as well as receiving some testing free of charge that would otherwise cost us as well as our Insurance.... I am grateful to be able to work really closely with the nutritionist during this time period learning as much as posible about Lane and his diet as well as receiving additional information about the extent of Lane's medical condition concerning his pancrease and digestive system . So Lane will start this next week...
First things first, we must weigh in... Wow, we (okay he) gained 4lbs.... we have been trying to gain weight for 6 months without gaining 1 single pound and we just made up for it.... Here is the proof!!! 46lbs...We get our blood pressure.. Lane then does his Pulse oximetry . He is always amused his finger is red... Brother Nick, does his sweat test (he was the last one to be tested) and his results were negative for CF... So all three older kids are CF free amen... Lane then did his pulmonary function test (PFT)... Scored .83 of the predicted 1.06 (not really sure if I just noted that correctly still learning).... We are counting on the score raising since Lane has only performed the test on two different occasions and they need a little practice :)This is the swab culture that Lane had done... This picture does not look so bad, but believe me he was GAGGING...... This is to test for Pseudomonas....This was the highlight for Lane.... He waited for this moment all week.... its ME... Yes Lane could not wait until mom had her poke... We are trying to determine on which side of the family the delta f508 gene is on, so it can easily narrow down testing for family members wanting to do gene testing to determine if they are a carrier or not... so this one is for you Lane... Love ya...Now it was time to enjoy the rest of the day with a treat. We ate some pizza and played some games... I have been trying to attach something fun with each visit... Hopefully always making good memories one visit at a time....And look, shortly after starting home Lane is out again.... wearing the well earned stickers across his shirt....Made it back home 10 hours later and started treatments all over again... Exhausted...We accepted the offer to join 40 other subjects from approximately 16 study sites in the US and Canada in a study for (PERT) Pancreatic Enzyme Replacement Therapy. Pert has contributed to a significant increase in the life span of CF patients. This study is for Ultrase MT12. In the past FDA did not require the approval of these drugs, however starting in April 2010 the FDA will be regulating and requiring approval of the safety and effectiveness of these enzymes. Lane is currently using Creon 10 and will continue to for the first half of the study and then switch to the Ultrase for the second half.... The study seems to require allot of information, but will only take place over the span of 38 days. So we are going to give it a try, knowing it will benefit the many CF patients that use the drug. Although we do not currently take Ultrase, I still feel we can benefit from participating as well. Hopefully we will discover which enzyme works best for Lane as well as receiving some testing free of charge that would otherwise cost us as well as our Insurance.... I am grateful to be able to work really closely with the nutritionist during this time period learning as much as posible about Lane and his diet as well as receiving additional information about the extent of Lane's medical condition concerning his pancrease and digestive system . So Lane will start this next week...
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