Whey-Based Enteral Formula Associated With Improved GI Tolerance in Children

A 100% whey-based enteral formula may be an alternative for children with enteral feeding intolerance. In a recent retrospective claims-based study, pediatric patients with various types of gastrointestinal (GI) dysfunction had lower rates of nausea, vomiting and other GI intolerance symptoms for up to 12 months after starting on whey formula. They also had fewer acute care visits and lower healthcare costs for at least six months after starting the formula.

Children receiving enteral (tube) feeds commonly experience feeding intolerance, says Senthilkumar Sankararaman, MD, a pediatric gastroenterologist at Cleveland Clinic. Symptoms may include abdominal distension, nausea, vomiting, diarrhea, constipation, and irritability or fussiness.

“Due to their underlying conditions, these kids may have difficulties with digestion, or stomach or intestinal motility,” he says. “There are some tests to assess such things, but they’re not always feasible or readily available. In practice, one approach is to determine whether symptoms improve after a change in enteral formula.”

Different types of enteral formula

There are different types of enteral formula based on modifications in nutrient contents, including proteins, carbohydrates and fats. Peptide-based formulas contain partially hydrolyzed proteins, which may be easier than intact proteins for some patients to digest and absorb.

Whey and casein are the two main milk proteins. Their relative proportions vary by species. For example, cow’s milk is approximately 80% casein and 20% whey, while mature human milk is closer to 40% casein and 60% whey, with an even higher whey proportion in early lactation.

“It is generally believed that whey proteins are gentler and easier to digest than casein,” Dr. Sankararaman says. “So, we retrospectively evaluated if a 100% whey protein formula product in patients with GI dysfunction was associated with better healthcare outcomes.”

Reduced GI symptoms

In the study, published in Clinical Nutrition ESPEN, researchers analyzed 2013-2023 claims records from a national database for more than 3,000 children ages 1-17. Patients had received a 100% whey-based peptide formula after having acute care for various types of GI dysfunction or conditions commonly linked to feeding intolerance, including cerebral palsy, gastroesophageal reflux disease (GERD), gastroparesis and short bowel syndrome. All patients had previously used another enteral formula.

Researchers assessed the patients’ clinical and economic outcomes 12 months before and up to 12 months after beginning the whey formula.

After formula initiation, claims associated with GI intolerance symptoms decreased. These included abdominal distension, abdominal pain, constipation, diarrhea, flatulence, gagging or retching, and nausea or vomiting.

Children with cerebral palsy, GERD and short bowel syndrome had significant reductions in overall GI intolerance through 12 months after formula initiation (P < .05). In children with gastroparesis, significant reductions were observed only through six months. All subgroups had significant reductions in nausea and vomiting through 12 months.

Reduced healthcare use

The analysis also showed significant reductions in the number of patients who visited emergency, inpatient and urgent care facilities after formula initiation (P < .05). Outpatient visit rates did not change, which Dr. Sankararaman notes may reflect the routine follow-up these children require regardless of symptom status.

In connection with reduced visits, healthcare costs also declined for up to six months after formula initiation (P < .001).

“In all of the assessments, we saw initial dramatic decrease in symptoms and healthcare use at one month, but rates began to gradually increase over time,” says Dr. Sankararaman, the lead author of the study. “As with any database study, we did not review granular data, so we can comment only on overall associations. We cannot infer a causation between the formula and the outcomes, and we definitely need prospective trials to evaluate this further.”

When to consider a 100% whey-based peptide formula

In pediatric gastroenterology and nutrition, clinicians often must make management decisions based on symptoms and response to interventions rather than definitive physiologic testing alone, Dr. Sankararaman notes.

“Although we cannot determine from this study whether the formula directly caused the observed improvements, these findings suggest that a 100% whey-based peptide formula may be reasonable to consider in pediatric patients with GI dysfunction or feeding intolerance who do not tolerate other enteral formulas,” he says.

Nestlé HealthCare Nutrition Inc. sponsored and funded this study. Dr. Sankararaman provided consulting services to Nestlé Health Science.