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Proton Pump Inhibitor
Proton Pump Inhibitors for Obesity (LiverLabPPI Trial)
Phase 4
Recruiting
Led By Valentina Shakhnovich, MD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
6-21 years of age
BMI ≥10th percentile for age (6-20 years of age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
LiverLabPPI Trial Summary
This trial tests whether obesity affects how well acid suppression medications work in children.
Who is the study for?
This trial is for children and young adults aged 6-21 with a BMI in the healthy range or higher, who may be generally healthy or have conditions like GERD, NAFLD, chronic abdominal pain, or obesity. Participants can currently be taking pantoprazole or lansoprazole. Those over 500lbs, with significant liver/renal impairment, pregnant/breastfeeding females, individuals with certain infections (hepatitis B/C/HIV), and those unable to undergo MRI due to metal implants are excluded.Check my eligibility
What is being tested?
The study investigates how obesity influences the effectiveness of acid suppression drugs in children. It involves administering Midazolam injection and Pantoprazole to observe their pharmacological effects over time in obese versus non-obese participants.See study design
What are the potential side effects?
Potential side effects from Midazolam include drowsiness, dizziness, nausea; while Pantoprazole might cause digestive issues like diarrhea or constipation, headache and potential long-term risks such as vitamin deficiencies.
LiverLabPPI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 21 years old.
Select...
My BMI is in the healthy range for my age.
Select...
I am over 20 years old with a BMI of at least 18.5.
LiverLabPPI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
plasma pharmacokinetics of pantoprazole
Secondary outcome measures
pharmacodynamics
pharmacokinetics of midazolam, if medication received to ease discomfort of pH probe study
safety of pantoprazole: incidence of reported and gastrointestinal adverse events
+1 moreSide effects data
From 2014 Phase 4 trial • 20 Patients • NCT0180128021%
Common cold
5%
Noro virus infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mycophenolate Mofetil (MMF)
MMF + PAN
EC-MPS
EC-MPS + PAN
LiverLabPPI Trial Design
2Treatment groups
Experimental Treatment
Group I: Not in Weight Management ProgramExperimental Treatment2 Interventions
Evaluate the effect of liver fat on drug metabolism of PPI's, and if applicable midazolam
Group II: In Weight Management ProgramExperimental Treatment2 Interventions
Evaluate the effect of liver fat on pharmacology of PPI's, and if applicable midazolam
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pantoprazole
2014
Completed Phase 4
~1500
Midazolam injection
2018
Completed Phase 4
~1450
Find a Location
Who is running the clinical trial?
Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,649 Total Patients Enrolled
Valentina Shakhnovich, MD5.02 ReviewsPrincipal Investigator - Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
Kathryn Kyler, MD, MSPrincipal InvestigatorChildren's Mercy Hospital Kansas City
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no GI tract issues, except for past surgeries like bariatric or Nissen fundoplication.I weigh more than 500lbs or 227kg.I cannot have blood drawn for tests.I have not had surgery on my stomach or intestines.I haven't taken specific medications that affect drug metabolism in the last week.I am taking or not taking pantoprazole or lansoprazole.My kidney function is low, with creatinine levels three times higher than normal for my age.You are afraid or uncomfortable in small, enclosed spaces.My body weight ranges from non-obese to obese.You have metal or other objects in your body that would prevent you from having an MRI scan.My liver tests are much higher than normal.I am generally healthy or have GERD, NAFLD, chronic abdominal pain, or obesity.I am between 6 and 21 years old.My BMI is in the healthy range for my age.I can stop taking lansoprazole or pantoprazole for 3 days if needed.I am over 20 years old with a BMI of at least 18.5.I haven't taken specific stomach acid reducers or consumed grapefruit juice in the last week.I do not have hepatitis B, C, or HIV.You have had a bad reaction to pantoprazole or similar medications in the past.I am pregnant or breastfeeding.I cannot or do not want to fast overnight before the study.
Research Study Groups:
This trial has the following groups:- Group 1: In Weight Management Program
- Group 2: Not in Weight Management Program
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are contributing to this experiment?
"Correct. According to the information on clinicaltrials.gov, this clinical trial is still recruiting participants and was initially announced on the 3rd of July 2018 with a most recent update occurring in March 28th 2022. The study aims to include 150 individuals across 1 site."
Answered by AI
To what degree is Pantoprazole a risk to those using it therapeutically?
"The safety profile of Pantoprazole is rated highly due to the Phase 4 trial status - signifying that this medication has already been approved for clinical use."
Answered by AI
What therapeutic purposes does Pantoprazole commonly fulfill?
"Pantoprazole is typically used to treat helicobacter pylori, though it may also be prescribed for individuals struggling with status epilepticus (convulsive), anxiolytic therapy or an unusual seizure pattern."
Answered by AI
Who makes up the ideal candidate for this clinical investigation?
"This study calls for 150 participants, between the age of 6 and 21. To be eligible, they must have a BMI above the 10th percentile (6-20 years old) or 18.5 (>20 years). Additionally, those with GERD, NAFLD, chronic abdominal pain or obesity can also apply if otherwise healthy. Pantoprazole or lansoprazole use is allowed but not required; all applicants should pass an MRI Hoop Test Clearance as well."
Answered by AI
Are there still open slots available for potential participants of this research?
"As per the clinicaltrials.gov listing, this medical study is actively seeking participants having been initially submitted on July 3rd 2018 with a subsequent update published 28th March 2022."
Answered by AI
Does the eligibility for this research encompass those aged 55 or older?
"This medical trial is seeking participants aged 6 and over, but below 21."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Oklahoma
How old are they?
18 - 65
What site did they apply to?
Children's Mercy Kansas City
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
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