AIM: To summarise the results from four clinical trials assessing the efficacy and safety of a thickening complex in the management of regurgitation in infants.
METHODS: Infants (n = 392) younger than 5 months presenting with at least five regurgitations per day were recruited in four open-label, interventional, single-group, multi-centric clinical trials sharing an identical design. The efficacy of four different formulae thickened with different thickening complexes of pectin, starch and locust bean gum, was evaluated on regurgitation at days 3, 14 and 90, and stools and growth at days 14 and 90.
RESULTS: The daily number of regurgitation episodes was significantly reduced at days 3 and 14 vs baseline in all studies (P < .001), with the largest decrease with the formula having the highest pectin content (study 1; P < .001). In all studies, growth was within normal range. A trend towards stool normalisation for consistency was observed in three studies at day 90 vs baseline and was significant in study 1 (P < .001). Stool frequency was unchanged by the interventions.
CONCLUSION: The four tested thickened formulae reduced regurgitation and were proven to be safe. The formula with the largest amount of pectin and lowest starch content showed the best efficacy.