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New treatment option for Infant Nutritional Physiological Phenomena
Official title Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
ClinicalTrials.gov ID: NCT05868408
What this study is testing
- What it's testing
- This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 28. Healthy volunteers may be eligible.
You may be able to join if
- Written informed consent has been obtained from at least one parent (or other 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
- For Saudi: Infant postnatal age ≤28 days (date of birth = day 0); For Philippines: Infant postnatal age ≥ 14 days and ≤ 28 days (date of birth = day...
You likely can't join if
- Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
- Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
- Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
- Infants with special dietary needs other than standard infant formula
- Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact...
- Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the...
See the full eligibility criteria
- Written informed consent has been obtained from at least one parent (or other 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
- For Saudi: Infant postnatal age ≤28 days (date of birth = day 0); For Philippines: Infant postnatal age ≥ 14 days and ≤ 28 days (date of birth = day 0).
- Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
- Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol
- Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
- Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
- Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
- Infants with special dietary needs other than standard infant formula
- Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
- Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
- Currently participating or having participated in another treatment clinical trial prior to enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Cavite City, Philippines
- Las Piñas, Philippines
- Jeddah, Saudi Arabia
- Riyadh, Saudi Arabia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 28 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cavite City, Philippines; Las Piñas, Philippines; Jeddah, Saudi Arabia; Riyadh, Saudi Arabia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.