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.

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 8 Months
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06633250
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Société des Produits Nestlé (SPN)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries	Germany, Italy, Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cow Milk Protein Allergy

Arms & Interventions

Arms

Experimental: Test Formula

Hydrolyzed rice protein formula

Active Comparator: Control Formula

Commercially available extensively hydrolyzed cow's milk formula

Interventions

Other: - Test Formula

Hydrolyzed rice protein formula

Other: - Control Formula

Commercially available extensively hydrolyzed cow's milk formula

Contact a Trial Team

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International Sites

Charité Universitätsmedizin Berlin, Berlin, Germany

Status

Address

Charité Universitätsmedizin Berlin

Berlin, ,

Site Contact

Brigit Kalb, Dr

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