249 - GI Symptom Improvement in Infants with Suspected CMPA Treated with Extensively Hydrolyzed Formula in a Clinical Setting: A Prospective Cohort Analysis

Poster Number: 249
Publication Number: 249.141

Michael J. Wilsey, USF Health Morsani College of Medicine, St. Petersburg, FL, United States; Lea V. Oliveros, Johns Hopkins All Children's Hospital, Saint Petersburg, FL, United States; Kathryn M. Kimsey, Johns Hopkins All Children's Hospital, Tampa, FL, United States; Grafton S. Barnett, Johns Hopkins All Children's Hospital, Harvest, AL, United States; Jerry M. Brown, Johns Hopkins All Children's Hospital, New port Richey, FL, United States

Background: Cow’s milk protein allergy (CMPA) occurs in 2-3% in infants. Long-term efficacy of extensively hydrolyzed formulas (EHF) in treating CPMA is well established. Parents and healthcare providers (HCP) prioritize rapid reduction of CMPA symptoms in the short-term as the main treatment goal.  Data regarding short-term efficacy of treating infants with CMPA with EHF is limited.

Objective: We sought to determine the short-term efficacy of gastrointestinal (GI) symptom relief in infants < 6 months of age with suspected CMPA treated with EHF containing the probiotic Lactobacillus rhamnosus GG (EHF-LGG), a probiotic previously shown to be efficacious in augmenting the clinical response of an extensively hydrolyzed formula in infants with CMPA.

Design/Methods: This is a prospective cohort analysis of de-identified survey data obtained from healthcare providers (HCP) treating 222 patients < 6 months of age with symptoms consistent with CMPA. Demographic data and baseline symptoms were collected via ZS Moments, a mobile app on an electronic device, by HCP. GI CMPA symptoms scored by severity from 0 to 3 (none, low, moderate, severe) at the first visit and were then started on an extensively hydrolyzed formula. Patients were reevaluated at follow-up to assess for changes in symptom severity and symptoms scoring was repeated. 

Results: Results are summarized in Table 1. Most HCP's (87%) involved in the survey were general pediatricians. Of 222 patients identified, 202 (91%) were included for symptom analysis.  55% were male and 59% had a family history of atopy. Most (~3/4) were newly diagnosed with CMPA, the majority (93%) were diagnosed by clinical assessment, and ~2/3 were seen in follow-up within 3 to 5 weeks. Symptom improvement was consistent across different follow-up visit durations between visit 1 and 2. The most common symptoms were diarrhea (n=117; 58%), regurgitation (n=142; 70%), abdominal pain (n=105, 52%), and belching (n=118, 58%). Of those with GI symptoms at visit 1, 93% (n=193) improved at visit 2.Conclusion(s): This is the largest prospective survey in the US examining short-term efficacy of GI symptom reduction using EHF-LGG in infants < 6 months with CMP. Analysis of this prospective cohort showed significant improvement in GI symptoms of CMPA in infants under 6 months of age when treated with extensively hydrolyzed formula. EHF-LGG appears to provide clinical relief and rapid reduction of GI symptoms in infants < 6 months of age with symptoms consistent with CMPA, often by the next follow-up visit.
Percentage of Patients Reporting Improvement of GI Symptoms at Visit 2