1039318- The Hematologic effects of prolonged proton pump inhibitor (PPI) treatment in pediatric patients
The purpose of this research is to determine the effect of prolonged (6 months or more) PPI therapy for extra-esophageal reflux (EER) and/or gastroesophageal reflux disease (GERD) on serum folate, B12, ferritin and iron levels, and RBC microscopic cellular appearance in children ages 0 to 18 years. This study is open until January 13, 2007.

This study is currently enrolling subjects during the patient’s office visit. Enrollment packets were mailed in January 2005 to patients living outside the mid-Missouri area. Enrollment and data collection will continue until at least 20 participants are enrolled there are currently 11 participants enrolled.

1043459- Outcomes of Pediatric Patients Previously Treated with Proton Pump Inhibitors
The purpose of this research is to obtain information about the outcomes of pediatric patients previously treated for EER and GERD. Information will be collected and compiled regarding: child’s symptoms and medications taken to treat reflux-related symptoms, including over-the-counter medications, motility medications; H 2-blockers and PPI medications. This study will remain open until December 2006. The study will close to new enrollment on March 1, 2006. Those already enrolled will be able to continue to purchase CaraCream or ChocoBase until December 1, 2006.

Enrollment flyers were sent out to approximately 650 potential participants mid-February 2005. Approximately 60 participants were enrolled by mid-March 2005. An enrollment goal of 300 participants is anticipated. The study team is currently working with data received from 130 respondents for the statistical analysis.

1044122- Concentration vs. Time of Proton Pump Inhibitors in Pediatric Patients
This study is being done to evaluate information about how children metabolize PPIs. Information will be collected and compiled regarding the child’s PPI medications and the results of his or her serum concentration vs. time results for PPIs prescribed for EER and GERD. This study is open until December 29, 2006.

Enrollment packets were mailed to potential participants mid-January 2005. Patients may enroll during their regular office visit with Dr. Bothwell as well. The study team is in the preliminary data-gathering stage. Enrollment and data collection will continue until at least 20 participants are enrolled.