Pediatric ObesityPhase 4LiverLabPPINCT04248335

Effect of Obesity on Proton Pump Inhibitors

A Phase 4 study testing Lansoprazole, Pantoprazole and Midazolam in people with Pediatric Obesity and NAFLD, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 6 to 21 yearsHealthy volunteers can take part
Conditions the study is for: Pediatric Obesity, NAFLD, GERD
What is being tested?: Lansoprazole, Pantoprazole and Midazolam
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 3 Jul 2018to 31 Dec 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 21 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

6-21 years of age
Obese and non-obese individuals
BMI ≥10th percentile for age (6-20 years of age)
BMI ≥18.5 (>20 years of age)
Otherwise healthy; or otherwise healthy with diagnosis of GERD, NAFLD, chronic abdominal pain or obesity, according to report of medical history and/or review of the medical record
Receiving or not receiving pantoprazole or lansoprazole for routine medical care
MRI Hoop Test Clearance

Who cannot join

Unable or unwilling to give written permission/assent/consent
For PO Study Drug: Any anatomic abnormality of the GI tract as defined by history, PE, or radiographic findings, including Bariatric surgery, Nissen fundoplication or equivalent surgery.
For IV Study Drug: Any anatomic abnormality of the GI tract as defined by history, PE, or radiographic findings, except Bariatric surgery, Nissen fundoplication or equivalent surgery.
For subjects undergoing weight management, treatment in the last 7 days with proton pump inhibitors omeprazole, esomeprazole, dexlansoprazole, or grapefruit juice.
For subjects not undergoing weight management, treatment in the last 7 days with medications known to clinically significantly inhibit (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, trazodone, valproic acid, topiramate) or induce (e.g., phenobarbital, carbamazepine, phenytoin) CYP2C19; and those known at therapeutic doses to significantly inhibit (e.g., erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, ketoconazole) or induce (e.g., oxcarbazepine, carbamazepine, phenytoin, phenobarbital, St. John's Wort, rifampin, rifapentine) or CYP3A4 activity in the last 7 days.
Unable to have blood drawn for the screening lab tests

Show all 17Show fewer

Unable or unwilling to fast overnight prior to the study session
Unable to have blood drawn for the screening lab tests
If taking lansoprazole or pantoprazole for clinical purposes, unable or unwilling to abstain from that PPI for 3 days prior to PK visit when the PPI is not the same as the study drug for that PK visit
Metal in the body or any foreign bodies that precludes MRI sequencing
Claustrophobia
Exceeds 500lbs or 227 kg in Body Weight
Demonstrated adverse reaction to previous pantoprazole or PPI exposure
Impaired hepatic activity as determined by routine liver function testing and defined as values ≥ 5 times the age-specific upper limit of normal (ULN) for AST, ALT, total bilirubin >2.0mg/dl, alkaline phosphatase ≥ 5 times the age-specific ULN
Impaired renal function defined as creatinine ≥ 3 times the age-specific ULN
Females of child-bearing age who are pregnant or breast-feeding
Any known infection with hepatitis B, C, or human immunodeficiency virus (HIV)

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Mercy Kansas City
Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Physiologic Determinants of PPI Disposition in Children

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

Read the detailed description

The purpose of this research study is to see how the body breaks down certain medicines. Many medicines are broken down in the liver. The liver is an organ in the belly. A person's age, size, genetics (DNA), and the health of their liver decide how quickly the body breaks down medicines and how much medication a person needs to take. Everybody's liver has some fat in it, but the amount of fat is different from person to person. The purpose of this study is to see if the amount of fat in the liver affects how quickly acid suppression medications start and stop working and get removed from the body.

Conditions: Pediatric Obesity, NAFLD, GERD
Being tested: Lansoprazole, Pantoprazole, Midazolam
Medical subject headings: Pediatric Obesity, Non-alcoholic Fatty Liver Disease, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LansoprazoleDrug
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.
PantoprazoleDrug
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.
MidazolamDrug
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.

Study groups in NCT04248335
Study group	Role	What they receive
Children enrolled to receive proton pump inhibitor	Experimental	Evaluate the effect of liver fat on pharmacology of PPI's, and if applicable midazolam Receives: Drug: Lansoprazole; Drug: Pantoprazole; Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma 1/2 Life (t1/2)
plasma elimination 1/2 life (t1/2)
Measured: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Weight-adjusted Clearance
Weight-adjusted Drug plasma clearance (CL/F)
Measured: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
AUC
Plasma Area Under the Curve
Measured: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Hepatic Fat Fraction
Hepatic Fat Fraction as measured by liver Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Measured: MRI obtained anytime within 30 days of PK visit
Tmax
Time to max plasma concentration
Measured: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Cmax
Weight-Adjusted maximum plasma concentration
Measured: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug

Secondary outcomes (1)

Inflammatory Cytokines
Mean and standard deviation of inflammatory cytokine levels measured from 58 of 71 participants who received pantoprazole. Cytokines include: INF-γ, IL-1β, IL-6.
Measured: Cytokines obtained from blood samples collected at pantoprazole PK study visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201831 Dec 2024

First posted30 Jan 2020
Study start3 Jul 2018
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pediatric ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04248335
Sponsor's protocol ID: STUDY00000201
Other IDs: K23DK115827-01A1
Acronym: LiverLabPPI
Status last verified: May 2026
First submitted: 27 Jan 2020
Last updated: 4 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Deidentified experimental data may be shared with institutional collaborators outside of CMH and if it is determined that biological samples obtained from study participants must be transferred to institutions outside of CMH for the purpose of confirmatory analyses, appropriate inter-institutional material transfer agreements will first be executed. As this is a pediatric study, minimal blood volumes are being collected and we do not anticipate that biological samples will be available to share with the outside community upon completion of the study, beyond those samples that may be required for confirmatory analyses.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pediatric Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiologic Determinants of PPI Disposition in Children
ClinicalTrials.gov ID: NCT04248335
Acronym / sponsor ID: LiverLabPPI / STUDY00000201
Conditions: Pediatric Obesity, NAFLD, GERD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 3 Jul 2018 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 30 Jan 2020 (actual)
Results: Posted 4 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Children enrolled to receive proton pump inhibitor	Experimental	Drug: Lansoprazole, Drug: Pantoprazole, Drug: MidazolamEvaluate the effect of liver fat on pharmacology of PPI's, and if applicable midazolam

Who may qualify

Ages: 6 to 21 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

6-21 years of age
Obese and non-obese individuals
Otherwise healthy; or otherwise healthy with diagnosis of GERD, NAFLD, chronic abdominal pain or obesity, according to report of medical history and/or review of the medical record
Receiving or not receiving pantoprazole or lansoprazole for routine medical care
MRI Hoop Test Clearance

Key exclusion criteria (17 listed)

Unable or unwilling to give written permission/assent/consent
For PO Study Drug: Any anatomic abnormality of the GI tract as defined by history, PE, or radiographic findings, including Bariatric surgery, Nissen fundoplication or equivalent surgery.
For IV Study Drug: Any anatomic abnormality of the GI tract as defined by history, PE, or radiographic findings, except Bariatric surgery, Nissen fundoplication or equivalent surgery.
For subjects undergoing weight management, treatment in the last 7 days with proton pump inhibitors omeprazole, esomeprazole, dexlansoprazole, or grapefruit juice.
For subjects not undergoing weight management, treatment in the last 7 days with medications known to clinically significantly inhibit (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine, ketoconazole, ticlopidine, felbamate, trazodone, valproic acid, topiramate) or induce (e.g., phenobarbital, carbamazepine, phenytoin) CYP2C19; and those known at therapeutic doses to significantly inhibit (e.g., erythromycin, clarithromycin, grapefruit juice, verapamil, diltiazem, cimetidine, ketoconazole) or induce (e.g., oxcarbazepine, carbamazepine, phenytoin, phenobarbital, St. John's Wort, rifampin, rifapentine) or CYP3A4 activity in the last 7 days.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lansoprazolesingle-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.	Drug	Children enrolled to receive proton pump inhibitor
Pantoprazolesingle-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.	Drug	Children enrolled to receive proton pump inhibitor
Midazolamsingle-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.	Drug	Children enrolled to receive proton pump inhibitor

Primary outcome

Plasma 1/2 Life (t1/2)
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
plasma elimination 1/2 life (t1/2)
Weight-adjusted Clearance
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Weight-adjusted Drug plasma clearance (CL/F)
AUC
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Plasma Area Under the Curve
Hepatic Fat Fraction
Time frame: MRI obtained anytime within 30 days of PK visit
Hepatic Fat Fraction as measured by liver Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Tmax
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Time to max plasma concentration
Cmax
Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug
Weight-Adjusted maximum plasma concentration

1 secondary outcome

Inflammatory Cytokines
Time frame: Cytokines obtained from blood samples collected at pantoprazole PK study visit.

Results and safety

Results posted to the registry on 4 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Receiving Proton Pump Inhibitors	76	76

Primary outcome: Plasma 1/2 Life (t1/2)

Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug. Mean (Standard Deviation). Unit: hours

Measure	Lansoprazole n = 41	Pantoprazole n = 25	Midazolam n = 0
Value	1.23 (0.77)	1.09 (1.03)	–

Population analysed: Noncompartmental analysis of lansoprazole included 41 participants at the time it was completed (when original PI left institution). Noncompartmental analysis of pantopraozle included 25 participants at the time it was completed (when original PI left institution). Noncompartmental pharmacokinetic analysis for midazolam was not started due to loss of personnel when original PI left institution. There is no future plan to analyze the data.

Primary outcome: Weight-adjusted Clearance

Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug. Mean (Standard Deviation). Unit: L//kg/hr

Measure	Lansoprazole n = 41	Pantoprazole n = 25	Midazolam n = 0
Value	0.18 (0.23)	0.1 (0.06)	–

Primary outcome: AUC

Time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug. Mean (Standard Deviation). Unit: microgram/mL*h

Measure	Lansoprazole n = 41	Pantoprazole n = 25	Midazolam n = 0
Value	3.4 (3.5)	6.5 (7.25)	–

Primary outcome: Hepatic Fat Fraction

Time frame: MRI obtained anytime within 30 days of PK visit. Mean (Standard Deviation). Unit: Hepatic Fat Fraction %

Measure	Lansoprazole n = 28	Pantoprazole n = 58	Midazolam n = 0
Value	2.82 (6.78)	3.0 (13.6)	–

Population analysed: We have MRI data on 28 participants who received lansoprazole (not all had MRI performed). We have MRI data on 58 participants who received pantoprazole (not all had MRI performed). Midazolam HFF not available (analysis stopped due to loss of personnel when original PI left institution, some participants may have had MRI but HFF data is not available as calculations were not completed). There is no future plan to analyze the data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment until end of pharmacokinetic study visit day, up to 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lansoprazole	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Pantoprazole	0 of 71 (0%)	0 of 71 (0%)	0 of 71
Midazolam	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Limitations and caveats (from the sponsor): Although our population model is based on a relatively small sample size (n=40), it is the only published model of PPI PK for obese children. Model-derived PK parameters were substantially different from those previously reported for non-obese children, who were not included in this study, as the study objective was to describe pantoprazole PK specifically for obese children.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Deidentified experimental data may be shared with institutional collaborators outside of CMH and if it is determined that biological samples obtained from study participants must be transferred to institutions outside of CMH for the purpose of confirmatory analyses, appropriate inter-institutional material transfer agreements will first be executed. As this is a pediatric study, minimal blood volumes are being collected and we do not anticipate that biological samples will be available to share with the outside community upon completion of the study, beyond those samples that may be required for confirmatory analyses.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathryn Kyler, MD, MS principal investigator

Children's Mercy Hospital Kansas City

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lansoprazole, Pantoprazole and Midazolam in people with Pediatric Obesity and NAFLD, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma 1/2 Life (t1/2) (time frame: samples collected at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours after ingestion of study PPI drug). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248335.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.