3. Results
fracture, constipation, feeding difficulties, viral gastroenteritis, regurgitation or fussing, trauma
ADVERSE EVENTS, URINARY INFECTION, VIRAL GASTROENTERITIS, BRONCHIOLITIS
Between June 2018 and December 2021, 70 patients were screened for eligibility. Due to the COVID-19 pandemic, inclusions were suspended between March and June 2020, as non-urgent medical appointments were impossible then. Then, due to the expiry date of the study milk cans, inclusions were stopped in December 2021. A total of 5 of the 70 screened patients declined to participate, and family consent was withdrawn for one other just after randomization. The ITT population consisted of 64 participants: 33 in the GMF group and 31 in the CMF group. Of these, 3 in the CMF group and 1 in the GMF group stopped treatment due to regurgitation or fussing (Demographic and clinical characteristics were similar between groups (Differences in five BEBQ subscale scores between baseline and day 28 ± 3 for the CMF and GMF groups were compared (QUALIN scores (According to MCH-FS scores, 2 (6%) GMF children had mild feeding difficulties and 1 (3%) CMF child had a moderate feeding difficulty at the end of follow-up (Finally, at the end of the study, parents were asked to use a four-level visual analog scale to evaluate how much their children liked the formula they were fed, and ratings did not differ between formula types (Overall, 10 non-serious adverse events were reported during the study period. In the CMF group, one patient had a fracture after a trauma, and another experienced bronchiolitis. In the GMF group, 3 patients suffered from constipation, 3 had viral gastroenteritis and 1 patient a urinary infection. None of these adverse events were linked to the study products by the investigators.