Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula

Cow Milk Allergy Clinical Trial

— STORY  

Official title:

A Single Arm, Open Label Intervention Study of a Hydrolyzed Protein Formula to Evaluate Growth, Safety and Tolerance in Infants With a Clinical Diagnosis of Cow's Milk Allergy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618704
• Other study ID #: SBB21R&38227
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Nutricia Research
• Contact: Danone Nutricia Research
• Phone: +31 30 2095 000
• Email: register.clinicalresearchnutricia[@]danone.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The main purpose of this study is to demonstrate adequate growth over a 16-week intervention period in cow's milk allergic infants receiving a hydrolyzed protein formula.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 8 Months

Eligibility

Inclusion Criteria:

1. Infants <8 months of age.

2. Infants with a clinical diagnosis of Cow's Milk Allergy (CMA) per local hospital practice, including any of the following criteria:

1. 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

2. 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

3. History of CoMiSS® score >10 indicating symptoms are likely cow's milk allergic prior to study entry

4. History of positive result of an oral food challenge with cow's milk prior to study entry

5. 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. 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.

4. Parents / guardians confirm their intention not to administer any products containing cow's milk protein during the study.

5. Expected to consume the specified age-dependent minimum amount of study product per day during the study.

6. Expected to require a milk substitute for CMA management for at least 16 weeks.

7. Written informed consent provided by parents / guardians, according to local law.

Exclusion Criteria:

1. Birth weight-for-age z-score <-2 Standard Deviation (SD) or >+2SD.

2. Infants <37 weeks gestation requiring specific premature formula at the time of study entry.

3. 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.

4. 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).

5. Infants with diagnosis of rice allergy or known allergy to any of the ingredients in the study product.

6. Investigator's uncertainty about the willingness or ability of the parents / guardians to comply with the protocol requirements.

7. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Related Conditions & MeSH terms

• Cow Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• Hydrolyzed protein infant formula
The subjects will take the formula for 16 weeks

Locations

Country	Name	City	State
Poland	Promed Medical Centre	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Research

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Growth	Weight, length, head circumference, BMI and corresponding World health Organization (WHO) z-scores	16 weeks
Other	Cow's milk related symptoms	CoMiSS and parent completed diary	16 weeks
Other	Gastrointestinal tolerance	Parent completed diary, incidence of gastrointestinal adverse effects. Tolerance will be evaluated on the basis of the number of gastrointestinal events including diarrhea, constipation, bloating, distension, nausea, vomiting, burping, flatulence and regurgitation and abdominal discomfort or pain reported for subjects during their participation in the study.	16 weeks
Other	Concentration of markers of mineral status in blood	Zinc (Zn); Calcium (Ca); Phosphate (P); Ferritin (Fe); Magnesium (Mg)	16 weeks
Other	Study product intake (ml/day) and complementary foods/drinks (food diary)	Parent completed diary	3 days prior to the last visit
Other	Study product appreciation	Parent completed questionnaire (questions with scales e.g., strongly agree - strongly disagree)	16 weeks
Primary	Adequate growth	Proportion of subjects with growth classified as adequate (by interpreting WHO z-scores weight-for-age and weight-for-length)	16 weeks