Smectite reduces gastroesophageal reflux in newborn infants.

We assessed the efficacy of a natural clay (smectite) on the frequency and the duration of acid (pH less than 4) and very acid (pH less than 3) gastroesophageal reflux (GER) measured by 24-hour continuous pH recording (CPR). Twenty newborn infants were enrolled in this double-blind controlled study owing to pathological CPR in supine position. After inclusion, all the patients were maintained in the 30-degree elevated prone position and received either smectite (3 g/day; n = 10) or placebo (n = 10) for 7 days. On the 8th day, a second 24-hour CPR was performed in supine position. The postural therapy alone (placebo group) was followed by a significant decrease in the numbers of acid GER (p less than 0.05) during the second CPR. The combination of postural therapy and smectite treatment was followed by a decrease in the number of acid (p less than 0.05) and very acid GER (p = 0.01), the percentages of time spent at pH below 4 (p less than 0.05) and 3 (p less than 0.01) and the maximal duration of acid GER (p less than 0.05).

RCT Entities:   Population Interventions Outcomes