A clinical trial with an “anti-regurgitation” formula

Abstract

To determine whether a new "anti-regurgitation formula" containing a bean gum preparation decreases the number of regurgitations and gastro-oesophageal reflux (GOR), we studied 20 infants from 1 week to 4 months of age, referred for evaluation of regurgitation, in a double-blind prospective study. The number of regurgitations decreased significantly 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, parental reassurance) (P 0.002 and 0.032, respectively). The results of a 24-h oesophageal pH monitoring, performed before and during treatment, showed a significant decrease in the percentage of time oesophageal pH was < 4.0 in the treatment group. It is concluded that conservative treatment of regurgitation in infants, consisting mainly of parental reassurance and postural therapy, is sufficient to obtain clinical remission in most patients. In addition, milk thickening products tend to improve clinical remission and contribute to the normalisation of some pH metric parameters.

A critical appraisal of current management practices for infant regurgitation - recommendations of a working party

“…The number of reflux episodes may increase or decrease [99], the oesophageal acid exposure increase depending on the baby's position [4]. The duration of the long-lasting reflux episodes has been reported to significantly increase [127,128] or remain unchanged [133]. These findings are in line with the recent observations in infants that increased food volume and osmolality increase the rate of TLORs and drifts in LOS pressure to almost undetectable levels [35].…”

“…Milk thickeners have been reported to reduce regurgitation in infants [4,92,99,127,128,133] and to improve sleep (possibly due to an improved satiety related to the higher caloric intake in the case of rice-thickened formula) [92]. However, their effects on the oesophageal acid exposure are inconsistent, as shown by pH monitoring [4,99,127,128,133] and scintigraphy [92] ( Table 1).…”

“…However, their effects on the oesophageal acid exposure are inconsistent, as shown by pH monitoring [4,99,127,128,133] and scintigraphy [92] ( Table 1). The number of reflux episodes may increase or decrease [99], the oesophageal acid exposure increase depending on the baby's position [4].…”

“…These recommendations were published prior to, or simultaneously with 'anti-prone-sleeping position' campaigns conducted and supported by governments and medical societies. Moreover, some of the recommendations of 1993 can be challenged upon critical analysis of the efficacy data, such as the effect of milk thickeners on pH-metric or scintigraphic parameters [4,92,99,127,128,133].…”

Comparison between pre-thickened and home-thickened formulas in gastroesophageal reflux treatment

“…Estudos demonstraram que a maior viscosidade do alimento reduz os episódios de RGE 15,16,[19][20][21] . O espessamento da dieta pode ser realizado através de fórmulas anti-regurgitação e da adição de hidratos de carbono (amido de cereais) ao leite 22 .…”