CompletedNCT04248335LiverLabPPIUpdated Jun 4, 2026Results posted

Effect of Obesity on Proton Pump Inhibitors

A Phase 4 interventional study of Lansoprazole and Pantoprazole in Pediatric Obesity, NAFLD and GERD, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 6 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Children's Mercy Hospital Kansas City · Phase 4, Interventional, and Treatment

From the registry’s dates

Registered 1 year 6 months after the study started (first participant enrolled Jul 2018, registered Jan 2020).

Phase: Phase 4
Study type: Interventional
Enrollment: 76
Allocation: Not applicable
Ages: 6 Years to 21 Years
Sex: All

Study summary

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 studied

Pediatric Obesity
NAFLD
GERD

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In context

Pediatric Obesity

1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.

This study's enrollment of 76 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 21 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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)

Study design

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

Study arms

Experimental
Children enrolled to receive proton pump inhibitor
Evaluate the effect of liver fat on pharmacology of PPI's, and if applicable midazolam
Drug: Lansoprazole · Drug: Pantoprazole · Drug: Midazolam

Interventions

DrugLansoprazole
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.
DrugPantoprazole
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.
DrugMidazolam
single-dose administration. Administered to a subset of participants who agreed to receive this drug upon enrollment.

What researchers measure

Primary outcomes

Plasma 1/2 Life (t1/2)
plasma elimination 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
Weight-adjusted Clearance
Weight-adjusted Drug plasma clearance (CL/F)
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
AUC
Plasma Area Under the Curve
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
Hepatic Fat Fraction
Hepatic Fat Fraction as measured by liver Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Time frame: MRI obtained anytime within 30 days of PK visit
Tmax
Time to max plasma concentration
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
Cmax
Weight-Adjusted maximum plasma concentration
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

Secondary outcomes

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

Results

Posted Jun 4, 2026

Limitations and caveats

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.

Participant flow

Subjects were recruited from the Gastroenterology clinic at Children's Mercy Kansas City. Subjects were also recruited from a pool of previous research participants, in the Divisions of Gastroenterology, Hepatology and Nutrition or Clinical Pharmacology, Toxicology and Therapeutic Innovation (the PI's home divisions), who had opted in to be contacted for future research opportunities. A notice was also be publicly displayed in the waiting areas of outpatient clinics at CMH.

Participant flow — Overall Study
Milestone	Participants Receiving Proton Pump Inhibitors
Started	76
Received lansoprazole	48
Received pantoprazole	71
Received midazolam	29
Completed	76
Not completed	0

Outcome measures

PrimaryPlasma 1/2 Life (t1/2)

plasma elimination 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
Reported as:: Mean · hours

Plasma 1/2 Life (t1/2)
hours	Lansoprazole	Pantoprazole	Midazolam
Plasma 1/2 Life (t1/2)	1.23 ± 0.77	1.09 ± 1.03	—

PrimaryWeight-adjusted Clearance

Weight-adjusted Drug plasma clearance (CL/F)

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
Reported as:: Mean · L//kg/hr

Weight-adjusted Clearance
L//kg/hr	Lansoprazole	Pantoprazole	Midazolam
Weight-adjusted Clearance	0.18 ± 0.23	0.1 ± 0.06	—

PrimaryAUC

Plasma Area Under the Curve

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
Reported as:: Mean · microgram/mL*h

AUC
microgram/mL*h	Lansoprazole	Pantoprazole	Midazolam
AUC	3.4 ± 3.5	6.5 ± 7.25	—

PrimaryHepatic Fat Fraction

Hepatic Fat Fraction as measured by liver Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)

Time frame:: MRI obtained anytime within 30 days of PK visit
Reported as:: Mean · Hepatic Fat Fraction %

Hepatic Fat Fraction
Hepatic Fat Fraction %	Lansoprazole	Pantoprazole	Midazolam
Hepatic Fat Fraction	2.82 ± 6.78	3.0 ± 13.6	—

PrimaryTmax

Time to max plasma concentration

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
Reported as:: Mean · hours

Tmax
hours	Lansoprazole	Pantoprazole	Midazolam
Tmax	1.73 ± 1.14	2.5 ± 0.7	—

PrimaryCmax

Weight-Adjusted maximum plasma concentration

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
Reported as:: Mean · microgram/mL/kg

Cmax
microgram/mL/kg	Lansoprazole	Pantoprazole	Midazolam
Cmax	2.49 ± 1.72	4.95 ± 2.83	—

SecondaryInflammatory 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.

Time frame:: Cytokines obtained from blood samples collected at pantoprazole PK study visit.
Reported as:: Mean · ng/L

Inflammatory Cytokines
ng/L	Pantoprazole + Midazolam	Lansoprazole
INF-γ levels	12.1 ± 36.8	—
IL-1β levels	1.07 ± 1.91	—
IL-6 levels	10.7 ± 29.55	—

Adverse events

Collected over From enrollment until end of pharmacokinetic study visit day, up to 24 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lansoprazole	0/48 (0%)	0/48 (0%)	0/48 (0%)
Pantoprazole	0/71 (0%)	0/71 (0%)	0/71 (0%)
Midazolam	0/29 (0%)	0/29 (0%)	0/29 (0%)

Baseline characteristics

76 participants enrolled to receive PPI study drug(s): 48 received lansoprazole (43 also received pantoprazole, 9 also received midazolam) 71 received pantoprazole (43 also received lansoprazole, 29 also received midazolam) 29 received midazolam (29 also received pantoprazole, and 9 also received lansoprazole)

Age, Categorical
Age, Categorical(Participants)	Participants Receiving PPI Study Drug(s)
<=18 years	69
Between 18 and 65 years	7
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Participants Receiving PPI Study Drug(s)
Female	41
Male	35

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Participants Receiving PPI Study Drug(s)
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	0
Black or African American	26
White	42
More than one race	7
Unknown or Not Reported	0

CYP2C19 Phenotype
CYP2C19 Phenotype(Participants)	Participants Receiving PPI Study Drug(s)
Poor metabolizer	2
Intermediate metabolizer	21
Normal metabolizer	25
Rapid metabolizer	19
Ultrarapid metabolizer	2
Data Missing	7

Weight Category
Weight Category(Participants)	Participants Receiving PPI Study Drug(s)
No Obesity	35
Obesity	41

Study locations

1 site

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

References and documents

Study documents

Protocol and statistical analysis plan · Dec 27, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04248335
Lead sponsor: Children's Mercy Hospital Kansas City
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party: Kate Kyler, MD, MSc (Physician Scientist, Children's Mercy Hospital Kansas City) — Principal investigator
First posted: Jan 30, 2020
Start date: Jul 3, 2018
Primary completion: Dec 31, 2024
Completion: Dec 31, 2024
Results posted: Jun 4, 2026
Last update: Jun 4, 2026

Study contacts

Kathryn Kyler, MD, MS

principal investigator · Children's Mercy Hospital Kansas City

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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