A standardised nutritional drink as a test meal for the 13C mixed triglyceride breath test for pancreatic exocrine insufficiency: A randomised, two‐arm crossover comparative study.

Background: The 13C mixed triglyceride breath test (13C MTGT) is a diagnostic test for pancreatic exocrine insufficiency (PEI). It is poorly standardised with much heterogeneity of the test meal, the commonest being toast and butter. A standardised oral nutritional supplement that could be easily transported, stored and made up would be valuable for making this test accessible outside of specialist centres. Methods: A prospective, randomised, two‐arm crossover study of different test meals was carried out in 14 healthy controls. The 13C MTGT was performed in identical conditions on two separate days. Two test meals were given in random order, either standard (toast and butter) or novel (oral nutritional supplement), with 250 mg of 13C‐labelled mixed triglyceride incorporated. Breath samples were taken postprandially to calculate cumulative percentage dose recovery (cPDR) of 13C at 6 h. Results: All 14 participants completed both arms of the study with no protocol deviations. The mean cPDR was 39.39% (standard deviation [SD] 5.19) for the standard test meal and 39.93% (SD 5.20) for the novel test meal. A one‐way repeated measures analysis of variance (ANOVA) found no significant difference in cPDR between the two meals, F(1, 13) = 0.18, p = 0.68 (minimum detectable difference of 0.81 at 80% power). Conclusion: This study demonstrates that a standardised oral nutritional supplement can be used without compromising 13C recovery. Using this test meal provides a standardised dietary stimulus to the pancreas, avoiding possible variation in quantity of dietary components with other test meals. Further, the ease of use of this method would help establish the 13C MTGT test more widely. Highlights: The 13C mixed triglyceride breath test (13C MTGT) is a useful diagnostic test mainly used in specialist centres.Lack of a standardised protocol is a key limitation to more widespread use.The test meal in particular shows much heterogeneity across the literature.A standardised oral nutritional supplement could make the 13C MTGT more versatile and robust.This two‐way, randomised crossover trial showed no difference in cumulative percentage dose recovery (cPDR) with a standardised oral nutritional supplement in comparison to toast and butter.This novel test meal minimises potential for error, negates the need for any kitchen equipment and could make the 13C MTGT more accessible for routine clinical use.Further validation studies in specific patient cohorts are needed. [ABSTRACT FROM AUTHOR]