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Zinc-L-carnosine supplement versus thickened formula for persistent infant regurgitation in randomized trialThickened Formula May Cost More Than This New Supplement

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Key Takeaway
Note Zinc-L-carnosine for infant regurgitation; reduced frequency and cost versus formula with no severe adverse events.

This two-center, prospective, single-blind, randomized, non-inferiority study was conducted in two Italian pediatric hospitals. The population included 60 infants aged 4 weeks to 7 months with persistent regurgitation despite appropriate nutritional and behavioral management. Participants were divided equally, with 30 in the Hepilor liquido® group and 30 in the thickened formula group. The follow-up duration was 8 weeks. The intervention was Hepilor liquido® (Zinc-L-carnosine-based supplement).

The primary outcome assessed symptom improvement based on the I-GERQ-R (Infant Gastro-Esophageal Reflux Questionnaire-Revised) score. Both groups showed significant improvement at 8 weeks. Regarding overall symptomatic remission, no statistically significant difference observed. However, results indicated a greater reduction in regurgitation frequency in the Hepilor liquido® group. Additionally, average treatment cost was significantly lower in the Hepilor® group compared to the comparator.

Safety data indicated no severe adverse events were recorded in both groups. Limitations were not reported in the provided evidence. While Zinc-L-carnosine is presented as a safe and effective alternative to thickened formula in treating persistent infant regurgitation after non-pharmacological measures fail, clinicians should note the specific subgroup characteristics. The study suggests potential benefits in frequency reduction and cost, but the lack of reported effect sizes or p-values limits definitive conclusions regarding superiority in the study.

Most babies spit up milk. It is normal. But when it keeps happening, parents worry. Doctors often suggest thickening the milk. This makes the baby feel full longer. But it can be hard to digest. It also costs a lot of money.

Parents want a better option. They want something that works without being too heavy on the stomach. They also want to save cash.

The surprising shift

For years, thickened formula was the go-to fix. It was the standard advice. But it has downsides. It can cause constipation. It can make gas worse. And it is expensive to buy every week.

But here is the twist. A new study looks at a different helper. It is called Zinc-L-carnosine. This ingredient protects the stomach lining. It fights inflammation. It acts like a shield for the gut.

What scientists didn't expect

This new helper is not a new drug. It is a supplement. It is used in adults often. But doctors did not use it much for babies. Now, a team in Italy tested it. They compared it to the old thickened formula.

They watched sixty infants closely. These babies were between four weeks and seven months old. They had already tried other fixes. Nothing worked well enough. So, they tried the new supplement or the thickened milk.

Think of your stomach like a busy road. Sometimes, the road gets blocked. Food gets stuck. This causes pain and spitting up.

Thickened formula tries to slow down the traffic. It makes the food move slower. But Zinc-L-carnosine works differently. It repairs the road itself. It fixes the cracks in the lining. When the lining is strong, acid cannot hurt the baby. The road stays clear.

The results were clear. Both groups got better. The babies felt less pain. The spitting up stopped for many of them.

But there was a difference. The group with the new supplement had fewer spit-ups. They had a bigger drop in frequency. The thickened formula group improved too. But the supplement seemed to work better at stopping the act of spitting up.

This doesn't mean this treatment is available yet.

The money part was huge. The supplement cost less. The thickened formula was pricier. Over eight weeks, families saved real money. There were no serious side effects in either group. Both were safe.

If your baby still spits up after trying other steps, talk to your doctor. Ask about new options. Do not stop current treatments without advice.

This study shows a new path. It offers a cheaper choice. It offers a lighter option for the tummy. But remember, every baby is different. What works for one might not work for another.

More research is needed. This study was small. It only had sixty babies. Bigger studies will follow. Scientists need to see if this works in more places. They also need to check long-term safety.

Approval takes time. Even if the science is good, regulators must review it. This process ensures safety for all children. Until then, doctors will decide who gets this new helper.

The future looks bright for parents. They have a new tool to help their little ones. It is safe. It is affordable. And it might just be the answer they have been looking for.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
BackgroundGastroesophageal reflux (GER) is a common physiological phenomenon in infants, typically self-limited, but often a source of parental concern. When non-pharmacological measures fail to improve symptoms, thickened formulas are commonly used. Zinc-L-carnosine (Polaprezinc) is a mucosal protectant with anti-inflammatory and antioxidant properties. It is widely used in gastrointestinal disorders in adults but has not yet been extensively studied in infants. We aim to evaluate the clinical effectiveness and cost impact of a Zinc-L-carnosine-based supplement (Hepilor liquido®) compared to thickened formula in infants with persistent regurgitation.MethodsThis was a two-center, prospective, single-blind, randomized, non-inferiority study conducted in two Italian pediatric hospitals. Infants aged 4 weeks to 7 months with persistent regurgitation despite appropriate nutritional and behavioral management were randomized to receive either Hepilor liquido® or thickened formula for 8 weeks. The primary outcome was symptom improvement based on the I-GERQ-R (Infant Gastro-Esophageal Reflux Questionnaire-Revised) score. Secondary outcomes included a reduction in regurgitation frequency and treatment cost analysis.ResultsSixty infants aged 4 weeks to 7 months were randomized to receive either Hepilor liquido® (n = 30, 50%) or thickened formula (n = 30, 50%) for 8 weeks. Both groups showed significant improvement in I-GERQ-R scores at 8 weeks. Although no statistically significant difference was observed in overall symptomatic remission, the Hepilor liquido® group demonstrated a greater reduction in regurgitation frequency. Notably, the average treatment cost was significantly lower in the Hepilor® group compared to the thickened formula. No severe adverse events were recorded in both groups.ConclusionsZinc-L-carnosine is a safe and effective alternative to thickened formula in treating persistent infant regurgitation, after the failure of non-pharmacological measures. Its lower cost and promising clinical effect support further investigation in larger pediatric cohorts.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT06678997, identifier: NCT06678997.
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