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Study Protocol Evaluating Hydrolyzed Rice Protein Formula Safety in Infants With Cow's Milk AllergyNew Rice Formula Could Help Kids With Milk Allergies

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Key Takeaway
Consider awaiting completed trial results before evaluating hydrolyzed rice protein-based formula for cow's milk allergy management.

This publication describes a protocol for a randomized controlled study designed to evaluate the safety and efficacy of a hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose. The target population consists of infants and children aged 60 days to 3 years with documented Immunoglobulin E-mediated cow's milk allergy. The study is planned as a multi-center trial with a maximum sample size of up to 67 children.

Participants will be assigned to receive either the hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose or an amino acid-based formula. The primary outcome seeks to demonstrate with 95% confidence that 90% of children with cow's milk allergy do not develop allergic reactions to the hydrolyzed rice protein-based formula under double-blind placebo-controlled food challenge conditions. Secondary outcomes include hydrolyzed rice protein-based formula intake, gastrointestinal tolerance during the week-long open challenge, and adverse events throughout the study.

No main results are reported in this document as it remains a protocol. Safety data regarding adverse events, serious adverse events, discontinuations, and tolerability are not reported. The follow-up period is defined as a 7-days open challenge with the hydrolyzed rice protein-based formula. Limitations and practice relevance are not reported in the source material.

Clinicians should note that this evidence represents a planned study rather than completed clinical data. Without reported outcomes or safety profiles, the intervention cannot currently be recommended based on this publication alone. Further investigation is required to determine the comparative benefits and risks relative to standard care options.

Imagine a parent rushing to the grocery store. They need a safe meal for their child who cannot drink cow's milk. The shelves are full of options, but many feel confusing or expensive.

Cow's milk allergy is common in young children. It causes rashes, stomach pain, and trouble breathing. Many families struggle to find safe food that tastes good and feels normal.

Current options often taste bitter or lack the nutrients babies need. Parents worry about hidden triggers in processed foods.

The surprising shift

Scientists have been looking for a better alternative. They know hydrolyzed rice formulas are safe. But they miss something important.

What scientists didn't expect

Human breast milk contains special sugars called HMOs. These sugars help gut health and fight germs. Most baby formulas do not have these sugars.

Think of your child's gut like a busy city street. Bad bacteria are like traffic jams that cause problems. Good bacteria keep things moving smoothly.

HMOs act like a special key that invites good bacteria to the party. They stop bad bacteria from causing trouble. This helps the child stay healthy and feel better.

Researchers are testing a new formula called RIGHT-HY. It mixes hydrolyzed rice protein with two types of HMOs.

The study includes babies and children aged two months to three years. They will eat the new formula for seven days. Doctors will watch for any allergic reactions carefully.

The study is still ongoing. No final results are ready yet. However, the team expects good news.

They hope 90% of children will eat the food without any allergic reactions. This would mean the formula is safe for most kids with milk allergies.

But there's a catch.

This is a research study, not a finished product on store shelves. Families cannot buy this formula right now.

Doctors say this research fills a big gap. There is little proof that rice formulas with HMOs are truly safe. This study will provide that proof.

If successful, it could change how doctors treat milk allergies. It offers a real choice for parents who want HMOs in their child's diet.

Talk to your pediatrician about your child's diet. Ask if a rice formula is right for them.

Wait for the study results before expecting this new option. It might take time to get approval.

The study is small. It only includes up to 67 children. Results from this group might not apply to every child.

Also, the formula is not available for purchase yet. It is only for research purposes.

Scientists will publish their results in medical journals soon. They will share what they learned at conferences.

If the formula passes safety tests, it could reach stores in the future. Until then, stick to the safe foods your doctor recommends.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
Hydrolyzed rice formulas (HRF) are a suitable option for the nutritional management of non-breastfed children with cow’s milk allergy (CMA). Human milk oligosaccharides (HMOs) enhance gastrointestinal health, promote the growth of beneficial gut microbiota, and may reduce the incidence of infections and antibiotic use. There is currently no evidence regarding the hypoallergenicity of HRF containing HMOs. The purpose of this study is to demonstrate the hypoallergenicity of a new hydrolyzed rice protein-based formula containing two manufactured HMOs (HRF-HMO). RIGHT-HY is a multi-center randomized controlled study enrolling infants and children (60 days–3 years) with documented Immunoglobulin E-mediated CMA. Children will be randomized in a crossover fashion to double-blind placebo-controlled food challenges (DBPCFC) with HRF-HMO and an amino acid-based formula (AAF)-HMO, followed by a 7-days open challenge with HRF-HMO requiring a daily minimum intake of 240 ml. Both formulas contain 2-fucosyllactose and lacto-N-neotetraose (1.5 g/L). The primary objective is to demonstrate with 95% confidence that 90% of children with CMA do not develop allergic reactions to HRF-HMO under DBPCFC conditions. Up to 67 children will be enrolled to meet the hypoallergenicity criteria. This sample size allows for a 10% drop-out rate and occurrence of one allergic reaction. An interim analysis will be performed after 42 children have completed both food challenges to assess whether hypoallergenicity criteria have been met, in which case, the study will be stopped for success. Secondary endpoints include HRF-HMO intake and gastrointestinal tolerance during the week-long open challenge, and adverse events throughout the study. The RIGHT-HY study was approved by ethical committees of all participating sites. This study will be the first to generate robust evidence on the hypoallergenicity of this rice formula with added HMOs in children with CMA. The results of the study will be disseminated in peer-reviewed publications and presentations at scientific conferences.Study protocol registrationhttps://clinicaltrials.gov/study/NCT06633289, identifier NCT06633289.
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