150 Participants Needed

Proton Pump Inhibitors for Obesity

(LiverLabPPI Trial)

VW
JD
SL
Overseen BySimone Lax
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.

Who Is on the Research Team?

KK

Kathryn Kyler, MD, MS

Principal Investigator

Children's Mercy Hospital Kansas City

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

MRI Hoop Test Clearance
I am taking or not taking pantoprazole or lansoprazole.
My body weight ranges from non-obese to obese.
See 4 more

Exclusion Criteria

I have no GI tract issues, except for past surgeries like bariatric or Nissen fundoplication.
Unable or unwilling to give written permission/assent/consent
I weigh more than 500lbs or 227kg.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are evaluated for the effect of liver fat on the pharmacology of PPIs and midazolam, if applicable

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pantoprazole
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Not in Weight Management ProgramExperimental Treatment2 Interventions
Group II: In Weight Management ProgramExperimental Treatment2 Interventions

Pantoprazole is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸
Approved in United States as Protonix for:
🇪🇺
Approved in European Union as Pantoprazole for:
🇨🇦
Approved in Canada as Pantoprazole for:
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Approved in Japan as Pantoprazole for:
🇨🇳
Approved in China as Pantoprazole for:
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Approved in Switzerland as Pantoprazole for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials
261
Recruited
941,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+
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