Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy. (RIGHT-GO)

Nestlé

Status: Not yet enrolling

Conditions: Cow Milk Protein Allergy

Treatments: Other: Control Formula; Other: Test Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT06633250

2204INF

Details and patient eligibility

About

The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).

Enrollment: 104 estimated patients

Sex: All

Ages: Under 8 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR]), if applicable)

2. Infant gestational age ≥ 37 completed weeks

3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg

4. Singleton birth

5. Infant age ≤ 8 months

6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk

7. Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:

   1. Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria/angioedema or vomiting, bloody streaks in stool, or respiratory symptoms
   2. For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present

8. Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study

9. Infant's parent(s)/LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol

Exclusion criteria

1. History of intolerance to eHF formula
2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
3. Major gastrointestinal disease / abnormalities (other than CMPA)
4. Known or suspected lactose intolerance or malabsorption
5. Known or suspected soy allergy
6. Glucose-galactose malabsorption
7. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).
8. Immunodeficiency
9. Persistent wheeze or chronic respiratory disease
10. Severe uncontrolled eczema
11. History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment
12. Weight-for-age value < -2 or > 2 standard deviations from the WHO Child Growth Standards median at enrollment
13. Height-for-age < -2 or > 2 standard deviations from the WHO Child Growth Standards median at enrollment
14. Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study
15. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups

Test Formula

Experimental group

Description:

Hydrolyzed rice protein formula

Treatment:

Other: Test Formula

Control Formula

Active Comparator group

Description:

Commercially available extensively hydrolyzed cow's milk formula

Treatment:

Other: Control Formula