Background
The [13C]-Spirulina platensis gastric emptying breath test (GEBT) with 5 samples is accurate relative to scintigraphy. This study was primarily designed to further validate this GEBT using a slightly different process for incorporating [13C] in Spirulina and to evaluate the utility of additional samples for assessing early gastric emptying.
Methods
After a 223 kcal test meal labeled with 99mTc and [13C]-Spirulina platensis, scintigraphic images and 5 breath samples (45, 90, 120, 180, and 240 minutes, GEBT5) were collected in 14 controls (Part A). In Part B, 9 breath samples were collected at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minutes (GEBT9) in 30 subjects (15 controls, 15 dyspepsia). Using correlation between [13C] breath excretion and scintigraphic emptying, lag time (t10, time for 10% emptying), emptying at 30 min (GE30), and half time (t50) were estimated for GEBT5 (Parts A and B) and GEBT9 (Part B).
Key Results
t50 values for scintigraphy, GEBT5, and GEBT9 were highly concordant. t10 by GEBT9 (90% CI, 6–15 minutes) was more strongly correlated (CCC 0.80 [95% CI, 0.63–0.90]) with scintigraphy (90% CI, 5–12 minutes), than GEBT5 (10–19 minutes, CCC 0.73 [95% CI, 0.54–0.85]). The correlation between estimated values (GEBT9) and linearly interpolated values (GEBT5) was closer at 60 (CCC 0.95 [95% CI, 0.91–0.97]) than 30 minutes (CCC 0.81 [95% CI, 0.71–0.89]).
Conclusions & Inferences
The [13C]-Spirulina platensis GEBT can accurately measure GE. While 5 and 9 samples are equally accurate for measuring t50, GEBT9 provides a more comprehensive assessment of early GE (t10 and GE30).