CompletedNot Applicable

Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula

Poland69 participantsStarted 2023-03-16

Plain-language summary

This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein formula.

Who can participate

Age range0 Days – 8 Months

SexALL

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Inclusion criteria

✓. Infants \<8 months of age.
✓. Infants with a clinical diagnosis of Cow's Milk Allergy (CMA) per local hospital practice, including any of the following criteria:
✓. Based on clinical examination with a careful history, parent-reported symptoms suggestive of CMA, and disappearance of the symptoms when cow's milk was eliminated from the diet for at least two weeks prior to study entry
✓. Based on clinical examination with a careful history, parent-reported symptoms suggestive of CMA, and disappearance of the symptoms while being breastfed with maternal cow's milk protein elimination diet for at least two weeks prior to study entry
✓. History of CoMiSS® score \>10 indicating symptoms are likely cow's milk allergic prior to study entry
✓. History of positive result of an oral food challenge with cow's milk prior to study entry
✓. Presence of specific Immunoglobulin E (IgE) to cow's milk protein based on skin prick test (wheel size ≥3mm) or radio-allergosorbent-test (RAST) (\>0.7 kilounit per liter (kU/L)) prior to or on the day of study entry.
✓. 3\. Infants that are still on dairy-derived extensively hydrolysed formula, amino acid-based formula, hydrolysed rice protein formula, soy-based formula or being breastfed by mothers who are on cow's milk protein elimination diet at study entry.

Exclusion criteria

✕. Birth weight-for-age z-score \<-2 Standard Deviation (SD) or \>+2SD.
✕. Infants \<37 weeks gestation requiring specific premature formula at the time of study entry.
✕. Infants with severe concurrent illness and/or have undergone gastrointestinal surgery such as bowel resection or stoma placement and/or with Down syndrome or other syndromes where functional gastrointestinal disorders are common.
✕. Infants that are more suitable to use Amino Acid Formula (AAF) as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using extensively Hydrolysed Formula (eHF)), faltering growth / failure to thrive, or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
✕. Infants with diagnosis of rice allergy or known allergy to any of the ingredients in the study product.
✕. Investigator's uncertainty about the willingness or ability of the parents / guardians to comply with the protocol requirements.
✕. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

What they're measuring

Adequate growth

Timeframe: 16 weeks

Trial details

NCT IDNCT05618704

SponsorNutricia Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-14

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