Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Qualit… (NCT06633250) | Clinical Trial Compass
RecruitingNot Applicable
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.
Germany, Italy104 participantsStarted 2024-10-25
Plain-language 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).
Who can participate
Age range8 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Weight-for-age z-score at 4 months post-enrollment
Timeframe: From enrollment to 4 months post-enrollment