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.

Not Applicable

Not yet recruiting

• Conditions: Cow Milk Protein Allergy
• Interventions: Other: Test Formula; Other: Control Formula

• Registration Number: NCT06633250
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Study Start: 2024-10-31
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Formula	Test Formula	Hydrolyzed rice protein formula
Control Formula	Control Formula	Commercially available extensively hydrolyzed cow's milk formula

Primary Outcome Measures

Name	Time	Method
Weight-for-age z-score at 4 months post-enrollment	From enrollment to 4 months post-enrollment	Weight measured in g and expressed in z scores according to the World Health Organization (WHO) Child Growth Standards.

Secondary Outcome Measures

Name	Time	Method
Weight	Monthly from enrollment to 4 months post-enrollment	Weight (g and z-scores)
Length	Monthly from enrollment to 4 months post-enrollment	Length (cm and z-scores)
Head circumference	At enrollmentn and 4 months post-enrollment	Head circumference (cm and z-scores)
Tibia lenght	At enrollmentn and 4 months post-enrollment	Tibia (cm)
Femur lenght	At enrollmentn and 4 months post-enrollment	Femur (cm)
Gastrointestinal Symptoms	First 7 days post enrollment	A daily GI tolerance questionnaire will be used.
Stool frequency and consistency	2 months and 4 months post-enrollment	A 3-day stool diary including the Brussels Infant and Toddler Stool Scale will be used.
Cow's Milk-related Allergy Symptom	Monthly from enrollment to 4 months post-enrollment	The Cow's Milk-related Symptom Score (CoMiSS) will be used to assess symptoms related to CMPA. The CoMiSS questionnaire contains 6 items and generates a score based on gastrointestinal, dermatological, respiratory, and general symptoms (total score range 0-33), which may be associated with CMPA .
Food Allergy Quality of Life	At enrollment and 4 months post-enrollment	The Food Allergy Quality of Life Questionnaire (FAQLQ-PF) will be used. It is a validated instrument with 30 items in 3 domains (emotional impact, food-related anxiety, dietary and social restrictions).
Parental self-efficacy in managing food allergy	At enrollment and 4 months post-enrollment	Parental self-efficacy in managing their child's food allergy will be assessed using the Food Allergy Self-Efficacy Scale for Parents (FASE-P). The FASE-P is a validated instrument with 21 items.
Parent-reported infant health-related quality of life	At enrollment and 4 months post-enrollment	Parent-reported infant health-related quality of life will be assessed using the Infant and Toddler Quality of Life Questionnaire - Short Form (ITQOL-SF47). The ITQOL-SF47 is a validated instrument with 47 items.
Complementary food intake	At enrollment, 2 months post-enrollment and 4 months post-enrollment	Total energy and macronutrient intake calculated from food recalls / diaries.
Formula compliance	Monthly from enrollment to 4 months post-enrollment	A questionnaire will be used to assess formula compliance.
Formula liking	4 months post-enrollment	A questionnaire will be used to assess formula liking.
Safety	From enrollment to 4 months post-enrollment	Adverse Events will be collected.

Trial Locations

Locations (19)

Korczowski Bartosz Gabinet Lekarski; 🇵🇱 Rzeszow, Poland

Alergo-Med Specjalistyczna Przychodnia Lekarska; 🇵🇱 Tarnow, Poland

University Hospital of Warsaw; 🇵🇱 Warszawa, Poland

Wojewodzki Szpital Specjalistyczny im. M. Kopernika; 🇵🇱 Lodz, Poland

ETG Lublin; 🇵🇱 Lublin, Poland

Poliklinika Ginekologiczno-Położnicza Arciszewscy; 🇵🇱 Bialystok, Poland

Centrum Medyczne Pratia; 🇵🇱 Bydgoszcz, Poland

IN-VIVO Bydgoszcz; 🇵🇱 Bydgoszcz, Poland

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny; 🇵🇱 Bydgoszcz, Poland

Vitamed Galaj i Cichomski; 🇵🇱 Bydgoszcz, Poland

BioMedical Centers; 🇵🇱 Janki, Poland

Centrum Medyczne Plejady; 🇵🇱 Krakow, Poland

Jagiellonian University Medical College; 🇵🇱 Kraków, Poland

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Naples, Italy

Azienda Ospedaliero Universitaria di Parma; 🇮🇹 Parma, Italy

AOUP Ospedale Santa Chiara; 🇮🇹 Pisa, Italy

Ospedale Pediatrico Bambino Gesu; 🇮🇹 Rome, Italy

AO Ordine Mauriziano; 🇮🇹 Turin, Italy