silicon and Diarrhea--Infantile

Epidemiological data on diarrhea due to Rotavirus are similar enough across different regions of the world to allow the pooling of clinical studies of Actapulgite for the treatment of acute diarrhea in infants and children in France and Africa. A total of 7,616 infants and children were entered into these open or placebo-controlled trials. Most patients were under two years of age, results of the analysis confirmed the antidiarrheal efficacy and safety of Actapulgite.

Topics: Acute Disease; Adolescent; Africa; Child; Child, Preschool; Clinical Trials as Topic; Diarrhea; Diarrhea, Infantile; France; Humans; Infant; Infant, Newborn; Magnesium; Magnesium Compounds; Rotavirus Infections; Silicon; Silicon Compounds

A placebo-controlled multicenter study was carried out to evaluate the effectiveness and safety of Actapulgite in infants and children with acute diarrhea. One hundred and thirteen patients, with a mean age of 28 months, were enrolled by pediatricians in the office. As recommended during acute diarrhea, the dosage of Actapulgite was doubled during the first three treatment days (2 to 4 packets a day according to the patient's weight), and reduced by half thereafter. The main effectiveness criteria was passage of the first normally formed stool, which denotes normalization of intestinal transit time. The first normally formed stool was recorded after two days of treatment with Actapulgite and was followed, on the next day, by a second normal stool, denoting complete recovery. The greater effectiveness of Actapulgite as compared with the placebo was demonstrated by the fact that both the first and the second normally formed stools were passed one day earlier with the active treatment (p = 0.01 and p = 0.002, respectively). In addition, resumption of a normal diet occurred significantly earlier with Actapulgite (4.4 days) than with the placebo (5.1 days). In addition to being effective, the study drug proved remarkably well tolerated. This study is especially valuable because of its office setting and the use of exclusively clinical criteria with a strict methodology.

Topics: Acute Disease; Adolescent; Child; Child, Preschool; Diarrhea; Diarrhea, Infantile; Double-Blind Method; Female; Humans; Infant; Magnesium; Magnesium Compounds; Male; Placebos; Silicon; Silicon Compounds