Abstract Background Gastrointestinal ultrasound (GIUS) is a method with both high sensitivity and specificity for evaluating disease activity in patients with Crohn’s disease. However, detecting and classifying stenosis and ulcerations can be challenging with GIUS. Developing an ultrasound method for detecting and categorising these findings would be of significant benefit to these patients. GIUS using an oral ultrasound contrast agent containing microbubbles is a new method with the potential to improve the intestinal ultrasound examination in patients with Crohn’s disease. The goal of this study is to investigate if intestinal ultrasound with oral contrast containing Sonazoid microbubbles in a PEG solution is a feasible and safe method in patients with Crohn’s disease. Methods 24 patients with Crohn’s disease in the terminal ileum (TI) was examined with ileocolonoscopy and intestinal ultrasound with oral contrast in a phase 2, single centre prospective cross-sectional drug trial. The ultrasound examination was done using Logiq E10 in contrast hybrid mode after ingestion of 1ml Sonazoid mixed with 500ml of PEG. The quality of the examination was graded 0-3 based on the amount of contrast in the lumen. In grade 3 the terminal ileum filled completely with contrast, and this was considered a successful examination. The contrast grade and transit time to TI after ingestion was documented along with symptoms, side effects and disease activity using "Mobile Health Index for Crohn’s Disease" before and after the study visit (1). Results All the included patients completed the ultrasound examination. The examination had a feasibility of 96 % as 23/24 patients achieved contrast effect grade 3 in TI with a clear separation of the intestinal wall and lumen. Average time from ingestion to grade 3 contrast effect in the TI was 20.8 min. Average duration of contrast effect grade 3 in the TI was 50.4 min. 50% of the patients had self-limiting diarrhea after the examination, however using paired samples T test there was no significant difference in average disease activity measured by MHICD before and after the examination (p=0.685). 96% of the patients agreed or completely agreed to undergo the examination again. Conclusion All except one patient achieved successful grade 3 contrast effect in the terminal ileum with a clear separation of the lumen and intestinal wall. Half of the patients had self-limiting diarrhea, but there was no increase in Crohn’s disease activity after the contrast examination. According to our study, ultrasound with oral contrast consisting of 1ml Sonazoid and 500ml PEG is a feasible and safe method to examine patients with Crohn’s disease.
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