BACKGROUND:Distressed behavior is common in infants and is often attributed to gastroesophageal reflux (GER) or food protein intolerance. OBJECTIVE: To examine the effect of a hypoallergenic amino acid-based infant formula (AAF) on distressed behavior and GER symptoms in infants who failed to respond to extensively hydrolyzed formula and antireflux medications. STUDY DESIGN:Nineteen distressed infants (9 boys and 10 girls; median age, 5.0 months) with presumed GER underwent gastroscopy (n = 17) and esophageal 24-hour pH monitoring (n = 14). Double-blind placebo-controlled (DBPC) formula challenges of AAF versus previously besttolerated formula were conducted. RESULTS: Nine infants had histologic evidence of esophagitis, and 9 had inflammatory changes in the stomach and/or duodenum. Symptoms remitted in all infants within 2 weeks of the start of feeding with AAF. On DBPC challenge after a median period of 3 months of receiving AAF, 12 infants were intolerant to active formula (distress score, 287 vs 580 min/wk,P =. 01; symptom score, 23.1 vs 36.1, P =.03). Seven infants did not relapse and were considered tolerant (distress score, 470 vs 581, P =.77; symptom score, 29.5 vs 20.2; P =.89). CONCLUSION: Treatment with AAF may reduce distressed behavior and symptoms of GER in infants with food protein intolerance.
RCT Entities:
BACKGROUND: Distressed behavior is common in infants and is often attributed to gastroesophageal reflux (GER) or food protein intolerance. OBJECTIVE: To examine the effect of a hypoallergenic amino acid-based infant formula (AAF) on distressed behavior and GER symptoms in infants who failed to respond to extensively hydrolyzed formula and antireflux medications. STUDY DESIGN: Nineteen distressed infants (9 boys and 10 girls; median age, 5.0 months) with presumed GER underwent gastroscopy (n = 17) and esophageal 24-hour pH monitoring (n = 14). Double-blind placebo-controlled (DBPC) formula challenges of AAF versus previously besttolerated formula were conducted. RESULTS: Nine infants had histologic evidence of esophagitis, and 9 had inflammatory changes in the stomach and/or duodenum. Symptoms remitted in all infants within 2 weeks of the start of feeding with AAF. On DBPC challenge after a median period of 3 months of receiving AAF, 12 infants were intolerant to active formula (distress score, 287 vs 580 min/wk,P =. 01; symptom score, 23.1 vs 36.1, P =.03). Seven infants did not relapse and were considered tolerant (distress score, 470 vs 581, P =.77; symptom score, 29.5 vs 20.2; P =.89). CONCLUSION: Treatment with AAF may reduce distressed behavior and symptoms of GER in infants with food protein intolerance.
Authors: Alessandro Fiocchi; Jan Brozek; Holger Schünemann; Sami L Bahna; Andrea von Berg; Kirsten Beyer; Martin Bozzola; Julia Bradsher; Enrico Compalati; Motohiro Ebisawa; Maria Antonieta Guzman; Haiqi Li; Ralf G Heine; Paul Keith; Gideon Lack; Massimo Landi; Alberto Martelli; Fabienne Rancé; Hugh Sampson; Airton Stein; Luigi Terracciano; Stefan Vieths Journal: World Allergy Organ J Date: 2010-04-23 Impact factor: 4.084