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Cow Milk Protein AllergyRIGHT-GONCT06633250

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.

A study testing Test Formula in people with Cow Milk Protein Allergy, run by Société des Produits Nestlé (SPN) at 19 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 8 months
Conditions the study is for
Cow Milk Protein Allergy
What is being tested?
Test Formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
19 sitesin 3 countries
Study dates
25 Oct 2024to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 8 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 11Show fewer
  • Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:
  • 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
  • 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
  • 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

Who cannot join

  • History of intolerance to eHF formula
  • Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria)
  • Major gastrointestinal disease / abnormalities (other than CMPA)
  • Known or suspected lactose intolerance or malabsorption
  • Known or suspected soy allergy
  • Glucose-galactose malabsorption
Show all 15Show fewer
  • Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).
  • Immunodeficiency
  • Persistent wheeze or chronic respiratory disease
  • Severe uncontrolled eczema
  • 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
  • Weight-for-age value < -2 or > 2 standard deviations from the WHO Child Growth Standards median at enrollment
  • Height-for-age < -2 or > 2 standard deviations from the WHO Child Growth Standards median at enrollment
  • 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
  • Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment

Trial locations and contacts

19 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Anthony de COZAR contact

+41762627426

anthony.decozar@rd.nestle.com

19 sites in 3 countries

Poland13 sites, 11 recruiting

  • Poliklinika Ginekologiczno-Położnicza Arciszewscy

    Bialystok

    Malgorzata Arciszewska, Dr

    Recruiting

  • Centrum Medyczne Pratia

    Bydgoszcz

    Oleg Warszalewski, Dr

    Recruiting

  • IN-VIVO Bydgoszcz

    Bydgoszcz

    Piotr Korbal, Dr

    Recruiting

  • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

    Bydgoszcz

    Anna Płoszczuk, Dr

    Recruiting

  • Vitamed Galaj i Cichomski

    Bydgoszcz

    Andrzej Galaj, Dr

    Recruiting

  • BioMedical Centers

    Janki

    Karolina Kolakowska, Dr

    Recruiting

  • Centrum Medyczne Plejady

    Krakow

    Completed

  • Jagiellonian University Medical College

    Krakow

    Urszula Jedynak-Wasowicz, Dr

    Recruiting

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika

    Lodz

    Agnieszka Brzozowska, Dr

    Recruiting

  • ETG Lublin

    Lublin

    Zofia Bartnik, Dr

    Recruiting

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów

    Bartosz Korczowski, Pr

    Recruiting

  • Alergo-Med Specjalistyczna Przychodnia Lekarska

    Tarnów

    Bernadetta Majorek-Olechowska

    Recruiting

  • University Hospital of Warsaw

    Warsaw

    Completed

Other trials in Poland

Italy5 sites, 4 recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples

    Roberto Berni Canani, Pr, berni@unina.it

    Recruiting

  • Azienda Ospedaliero Universitaria di Parma

    Parma

    Susanna Esposito, Pr

    Recruiting

  • AOUP Ospedale Santa Chiara

    Pisa

    Completed

  • Ospedale Pediatrico Bambino Gesu

    Rome

    Vincenzo Fierro, Dr

    Not yet recruiting

  • AO Ordine Mauriziano

    Turin

    Emilia Parodi, Dr

    Recruiting

Other trials in Italy

Germany1 site, 1 recruiting

  • Charité Universitätsmedizin Berlin

    Berlin

    Brigit Kalb, Dr, birgit.kalb@charite.de

    Recruiting

Other trials in Germany

About this study

Official title: 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: a Randomized Nutritional Clinical Study

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).

Being tested
Test Formula, Control Formula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test FormulaOther

    Hydrolyzed rice protein formula

  • Control FormulaOther

    Commercially available extensively hydrolyzed cow's milk formula

Study groups in NCT06633250
Study groupRoleWhat they receive
Test FormulaExperimentalHydrolyzed rice protein formula
Receives: Other: Test Formula
Control FormulaActive comparatorCommercially available extensively hydrolyzed cow's milk formula
Receives: Other: Control Formula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to 4 months post-enrollment

Secondary outcomes (17)

  1. Weight

    Weight (g and z-scores)

    Measured: Monthly from enrollment to 4 months post-enrollment

  2. Length

    Length (cm and z-scores)

    Measured: Monthly from enrollment to 4 months post-enrollment

  3. Head circumference

    Head circumference (cm and z-scores)

    Measured: At enrollmentn and 4 months post-enrollment

  4. Tibia lenght

    Tibia (cm)

    Measured: At enrollmentn and 4 months post-enrollment

  5. Femur lenght

    Femur (cm)

    Measured: At enrollmentn and 4 months post-enrollment

  6. 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.

    Measured: Monthly from enrollment to 4 months post-enrollment, and 7 days after enrollment

  7. Gastrointestinal Symptoms

    A daily GI tolerance questionnaire will be used.

    Measured: First 7 days post enrollment

  8. Stool frequency and consistency

    A retrospective 1-day stool record including the Brussels Infant and Toddler Stool Scale will be used.

    Measured: At enrollment

  9. Stool frequency and consistency

    A 3-day stool diary including the Brussels Infant and Toddler Stool Scale will be used.

    Measured: 2 months and 4 months post-enrollment

  10. 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 .

    Measured: Monthly from enrollment to 4 months post-enrollment

  11. 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).

    Measured: At enrollment and 4 months post-enrollment

  12. 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.

    Measured: At enrollment and 4 months post-enrollment

  13. 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.

    Measured: At enrollment and 4 months post-enrollment

  14. Complementary food intake

    Total energy and macronutrient intake calculated from food recalls / diaries.

    Measured: At enrollment, 2 months post-enrollment and 4 months post-enrollment

  15. Formula compliance

    A questionnaire will be used to assess formula compliance.

    Measured: Monthly from enrollment to 4 months post-enrollment

  16. Formula liking

    A questionnaire will be used to assess formula liking.

    Measured: 4 months post-enrollment

  17. Safety - Occurence of AE

    Adverse Events will be collected.

    Measured: From enrollment to 4 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start25 Oct 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06633250
Sponsor's protocol ID
2204INF
Acronym
RIGHT-GO
Status last verified
Dec 2025
First submitted
7 Oct 2024
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 42111853

Questions about this trial

What is this clinical trial studying?

A study testing Test Formula in people with Cow Milk Protein Allergy, run by Société des Produits Nestlé (SPN) at 19 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Poland, Italy, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anthony de COZAR (+41762627426, anthony.decozar@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight-for-age z-score at 4 months post-enrollment (time frame: From enrollment to 4 months post-enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06633250, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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