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Validation of a stable isotope gastric emptying test for normal, accelerated or delayed gastric emptying

To validate a 13C‐Spirulina platensis breath test for measurement of accelerated or delayed gastric emptying, we measured gastric emptying of egg containing 13C‐S. platensis and 99mTc‐sulphur colloid by breath 13 CO2 every 15 min over 3 h and scintigraphy every 15–30 min over 5 h in 57 healthy volunteers. Thirty‐three received no treatment, 10 received erythromycin, and 14 atropine. A generalized linear regression model predicted half‐emptying time by scintigraphy (t1/2S) from breath 13CO2 (t1/2B) data. Accuracy was assessed by standard deviation (SD) of differences between t1/2S and t1/2B and by receiver operating characteristic (ROC) curves. Regression models using breath samples at baseline, and 45, 90, 105 and 120 min, predicted t1/2B (mean ± SD) at 118 ± 59 min, similar to t1/2S (118 ± 67 min). Correlation between t1/2B and t1/2S was significant (r=0.88; P < 0.0001). Differences between t1/2S and t1/2B were: 18–19.2 min for t1/2 < 70–150 min, and 68.3 min for t1/2 > l50 min. Breath test detected abnormal emptying with a sensitivity of 86% and specificity of 80%. Thus, the 13C‐S. platensis test measures gastric emptying t1/2 for solids, which is accelerated or delayed to mimic a range of conditions from dumping syndrome to severe gastroparesis, with high sensitivity and specificity. Additional breath samples are needed to increase sensitivity in detecting accelerated gastric emptying.