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Cow's Milk–Associated Gastrointestinal Symptoms Evaluated Using the Double-Blind, Placebo-Controlled Food Challenge

Merras-Salmio, Laura*; Pelkonen, Anna S.; Kolho, Kaija-Leena*; Kuitunen, Mikael; Mäkelä, Mika J.

Journal of Pediatric Gastroenterology and Nutrition: September 2013 - Volume 57 - Issue 3 - p 281–286
doi: 10.1097/MPG.0b013e3182993fe0
Original Articles: Gastroenterology

Objective: The aim of this study was to evaluate the suspicion of cow's-milk allergy in infants with unspecific gastrointestinal (GI) symptoms using the double-blind, placebo-controlled food challenge.

Methods: A prospective cohort study, which recruited 57 consecutive children with gastrointestinally manifested symptoms suspected of cow's-milk allergy. All patients underwent a 5-day double-blind, placebo-controlled food challenge for cow's milk.

Results: The median age of the patients was 8.7 months. None had measurable cow's-milk–specific IgE. The food challenge was positive in 18 (32%) cases, with symptoms manifesting within 48 hours in 17 of 18 cases. The only symptom that correlated with the positive challenge was loose stools, reported as a presenting symptom in 78% of challenge-positive and in 46% of challenge-negative children (P = 0.043). During active challenge, the respective proportions were 82% and 2% (P < 0.0001). No serious adverse effects were manifested during the challenges. In the challenge-negative group, significant placebo reactions occurred in 18 (46%) patients. In the challenge-negative children, adult-type hypolactasia genotype CC frequency was higher (31%, P = 0.033) than national prevalence of 18%.

Conclusions: In an infant with unspecific GI symptoms suspected of cow's-milk allergy, this diagnosis is seldom confirmed. Other reasons for the troublesome GI symptoms should also be identified.

*Division of Pediatric Gastroenterology, Children's Hospital

Department of Allergology, Helsinki University Central Hospital, Helsinki, Finland.

Address correspondence and reprint requests to Laura Merras-Salmio, Helsinki University Children's Hospital, PO Box 281, FIN-00029 HUS, Finland (e-mail:

Received 28 February, 2013

Accepted 27 April, 2013

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Funding for this work has been received from the Lahja and Väinö Kivi Foundation, Päivikki and Sakari Sohlberg Foundation, and Helsinki University Hospital Research Grant.

The authors report no conflicts of interest.

© 2013 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,