A CLINICAL-TRIAL WITH AN ANTI-REGURGITATION FORMULA

To determine whether a new ''anti-regurgitation formula'' containing a bean gum preparation decreases the number of regurgitations and gastr o-oesophageal reflux (GOR), we studied 20 infants from 1 week to 4 mon ths of age, referred for evaluation of regurgitation, in a double-blin d prospective study. The number of regurgitations decreased significan tly in both the treatment group (the formula with thickening product, positional treatment, parental reassurance) and the placebo group (the same formula without thickening product, positional treatment, parent al reassurance) (P 0.002 and 0.032, respectively). The results of a 24 -h oesophageal pH monitoring, performed before and during treatment, s howed a significant decrease in the percentage of time oesophageal pH was < 4.0 in the treatment group. It is concluded that conservative tr eatment of regurgitations in infants, consisting mainly of parental re assurance and postural therapy, is sufficient to obtain clinical remis sion in most patients. In addition, milk thickening products tend to i mprove clinical remission and contribute to the normalisation of some pH metric parameters.