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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Formula | Experimental | Hydrolyzed rice protein formula |
|
| Control Formula | Active Comparator | Commercially available extensively hydrolyzed cow's milk formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Formula | Other | Hydrolyzed rice protein formula |
| |
| Control Formula |
| Measure | Description | Time Frame |
|---|---|---|
| Weight-for-age z-score at 4 months post-enrollment | Weight measured in g and expressed in z scores according to the World Health Organization (WHO) Child Growth Standards. | From enrollment to 4 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight (g and z-scores) | Monthly from enrollment to 4 months post-enrollment |
| Length | Length (cm and z-scores) | Monthly from enrollment to 4 months post-enrollment |
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Inclusion Criteria:
Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR]), if applicable)
Infant gestational age ≥ 37 completed weeks
Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
Singleton birth
Infant age ≤ 8 months
Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:
Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony de COZAR | Contact | +41762627426 | anthony.decozar@rd.nestle.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin Berlin | Recruiting | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42111853 | Derived | Zemrani B, Hays NP, Darwish N, Beyer K, Berni Canani R, Szajewska H; RIGHT-GO Consortium. Growth and safety of infants with cow's milk allergy receiving a new hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose: protocol for a randomized clinical trial. The RIGHT-GO study. Front Nutr. 2026 Apr 24;13:1784490. doi: 10.3389/fnut.2026.1784490. eCollection 2026. |
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| Other |
Commercially available extensively hydrolyzed cow's milk formula |
|
| Head circumference | Head circumference (cm and z-scores) | At enrollmentn and 4 months post-enrollment |
| Tibia lenght | Tibia (cm) | At enrollmentn and 4 months post-enrollment |
| Femur lenght | Femur (cm) | At enrollmentn and 4 months post-enrollment |
| Gastrointestinal Symptoms | The Infant Gastrointestinal Symptom Questionnaire (IGSQ) will be used to assess GI tolerance. The IGSQ is a validated instrument that includes 13 questions in 5 domains (stooling, spitting-up/vomiting, crying, fussiness, and flatulence) and total scores range from 13 (best) to 65 (worst) for overall GI symptom burden. | Monthly from enrollment to 4 months post-enrollment, and 7 days after enrollment |
| Gastrointestinal Symptoms | A daily GI tolerance questionnaire will be used. | First 7 days post enrollment |
| Stool frequency and consistency | A retrospective 1-day stool record including the Brussels Infant and Toddler Stool Scale will be used. | At enrollment |
| Stool frequency and consistency | A 3-day stool diary including the Brussels Infant and Toddler Stool Scale will be used. | 2 months and 4 months post-enrollment |
| Cow's Milk-related Allergy Symptom | 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 . | Monthly from enrollment to 4 months post-enrollment |
| Food Allergy Quality of Life | 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). | At enrollment and 4 months post-enrollment |
| Parental self-efficacy in managing food allergy | 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. | At enrollment and 4 months post-enrollment |
| Parent-reported infant health-related quality of life | 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. | At enrollment and 4 months post-enrollment |
| Complementary food intake | Total energy and macronutrient intake calculated from food recalls / diaries. | At enrollment, 2 months post-enrollment and 4 months post-enrollment |
| Formula compliance | A questionnaire will be used to assess formula compliance. | Monthly from enrollment to 4 months post-enrollment |
| Formula liking | A questionnaire will be used to assess formula liking. | 4 months post-enrollment |
| Safety - Occurence of AE | Adverse Events will be collected. | From enrollment to 4 months post-enrollment |
| Azienda Ospedaliera Universitaria Federico II | Recruiting | Naples | Italy |
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| Azienda Ospedaliero Universitaria di Parma | Recruiting | Parma | Italy |
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| AOUP Ospedale Santa Chiara | Completed | Pisa | Italy |
| Ospedale Pediatrico Bambino Gesu | Not yet recruiting | Rome | Italy |
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| AO Ordine Mauriziano | Recruiting | Turin | Italy |
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| Poliklinika Ginekologiczno-Położnicza Arciszewscy | Recruiting | Bialystok | Poland |
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| Centrum Medyczne Pratia | Recruiting | Bydgoszcz | Poland |
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| IN-VIVO Bydgoszcz | Recruiting | Bydgoszcz | Poland |
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| Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny | Recruiting | Bydgoszcz | Poland |
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| Vitamed Galaj i Cichomski | Recruiting | Bydgoszcz | Poland |
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| BioMedical Centers | Recruiting | Janki | Poland |
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| Centrum Medyczne Plejady | Completed | Krakow | Poland |
| Jagiellonian University Medical College | Recruiting | Krakow | Poland |
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| Wojewodzki Szpital Specjalistyczny im. M. Kopernika | Recruiting | Lodz | Poland |
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| ETG Lublin | Recruiting | Lublin | Poland |
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| Korczowski Bartosz Gabinet Lekarski | Recruiting | Rzeszów | Poland |
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| Alergo-Med Specjalistyczna Przychodnia Lekarska | Recruiting | Tarnów | Poland |
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| University Hospital of Warsaw | Completed | Warsaw | Poland |