Severe gastroesophageal reflux disease and cow milk hypersensitivity in infants and children: disease association and evaluation of a new challenge procedure

J Pediatr Gastroenterol Nutr. 2004 Oct;39(4):383-91. doi: 10.1097/00005176-200410000-00015.


Background: Gastroesophageal reflux disease (GERD) and cow milk hypersensitivity are frequent disorders of infancy. A possible causative association between these two entities has been suggested.

Objective: The primary aim was to elucidate whether a causative relationship between the two entities could be established in a population of infants and children. A secondary aim was to evaluate whether cow milk challenge during esophageal pH monitoring is useful as an objective method to identify this subgroup of patients.

Methods: Upper endoscopy followed by a 48-hour esophageal pH monitoring with cow's milk elimination diet at day 1 and challenge at day 2. Cow milk hypersensitivity was later verified by elimination diet and a second open (in patients < 3 years of age) or double-blind placebo-controlled (in patients > or = 3 years of age) challenge. Skin prick test, specific serum immunoglobulin E and skin patch test were used as supplementary procedures. Follow-up endoscopy and pH monitoring were performed after 3 months of treatment (omeprazole versus elimination diet dependent on evidence of food hypersensitivity).

Results: Eighteen of 42 investigated patients had severe GERD, defined as endoscopic esophagitis and/or a reflux index > 10%. Among these patients, a group of 10 patients with GERD and cow milk hypersensitivity was identified. This group had a significantly higher reflux index compared with children with primary GERD. No significant increase was noted in reflux index during simultaneous pH monitoring and milk challenge.

Conclusions: An association between GERD and cow milk hypersensitivity was observed in both infants and children with severe GERD. Simultaneous cow milk challenge and pH monitoring had limited value as a method to identify this subgroup.

Publication types

  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Animals
  • Cattle
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Endoscopy, Gastrointestinal
  • Esophagus / chemistry
  • Gastroesophageal Reflux / complications*
  • Gastroesophageal Reflux / diagnosis
  • Humans
  • Hydrogen-Ion Concentration
  • Infant
  • Milk Hypersensitivity / complications*
  • Milk Hypersensitivity / diagnosis
  • Milk Hypersensitivity / diet therapy
  • Placebos
  • Skin Tests


  • Placebos