13 C-Spirulina Gastric Emptying Breath Test Normative Values in Healthy Children: A Multicenter Study With Comparison to Symptomatic Children.

INTRODUCTION

Diagnosing pediatric gastroparesis presents a significant challenge due to lack of normative data in children. We aimed to determine normative values for gastric emptying using the nonradioactive 13 C-Spirulina gastric emptying breath test ( 13 C-GEBT) in a large cohort of healthy children (HC) and examine differences compared to children with gastroparesis-like symptoms (GLS).

METHODS

A total of 301 HC ages 7-18 years completed the 13 C-GEBT with 10 different breath samples × 4 hours. 13 CO 2 excretion rate (kPCD) was determined by change in 13 CO 2 / 12 CO 2 . Outcome variables included: kPCD at 10 time points, peak (maximum) kPCD, time to peak (T max ) kPCD, and area under curve (AUC) of 13 CO 2 excretion, along with breath test half emptying time (BT t ½ ). Results were compared with 13 C-GEBT data from peripubertal and postpubertal patients 11-18 years of age with GLS.

RESULTS

A total of 216 HC, 51.4% female, completed the test meal within the allotted time. Females vs. males had lower peak kPCD ( P = 0.003), longer T max ( P = 0.04), lower AUC ( P < 0.001), and longer BT_t ½ ( P < 0.0001). Peak kPCD ( P = 0.01, P < 0.001) and AUC ( P = 0.012, P < 0.001) were higher in prepubertal vs peri pubertal and postpubertal children. BT_t ½ and T max were shorter in HC vs. GLS ( P < 0.001, P < 0.0001, respectively), consistent with faster gastric emptying in HC. Normative reference values based on 5th percentile kPCD and T max were established for peripubertal and postpubertal females. An algorithm incorporating key variables demonstrated 80.8% sensitivity for diagnosis of gastroparesis.

DISCUSSION

This study demonstrates sex and pubertal differences in gastric emptying in children and provides the first reference values for female children.