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.
NCT ID: NCT06633250
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2024-10-25
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Test Formula
Hydrolyzed rice protein formula
Test Formula
Hydrolyzed rice protein formula
Control Formula
Commercially available extensively hydrolyzed cow's milk formula
Control Formula
Commercially available extensively hydrolyzed cow's milk formula
Interventions
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Test Formula
Hydrolyzed rice protein formula
Control Formula
Commercially available extensively hydrolyzed cow's milk formula
Eligibility Criteria
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Inclusion Criteria
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
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
8 Months
ALL
No
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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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
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
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, , Poland
ETG Lublin
Lublin, , Poland
Korczowski Bartosz Gabinet Lekarski
Rzeszów, , Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska
Tarnów, , Poland
University Hospital of Warsaw
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Brigit Kalb, Dr
Role: primary
Roberto Berni Canani, Pr
Role: primary
Susanna Esposito, Pr
Role: primary
Vincenzo Fierro, Dr
Role: primary
Emilia Parodi, Dr
Role: primary
Malgorzata Arciszewska, Dr
Role: primary
Oleg Warszalewski, Dr
Role: primary
Piotr Korbal, Dr
Role: primary
Anna Płoszczuk, Dr
Role: primary
Andrzej Galaj, Dr
Role: primary
Karolina Kolakowska, Dr
Role: primary
Urszula Jedynak-Wasowicz, Dr
Role: primary
Agnieszka Brzozowska, Dr
Role: primary
Zofia Bartnik, Dr
Role: primary
Bartosz Korczowski, Pr
Role: primary
Bernadetta Majorek-Olechowska
Role: primary
Other Identifiers
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2204INF
Identifier Type: -
Identifier Source: org_study_id