New study hopes to soothe mild allergies in babies with special formula
NCT ID NCT07449507
First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 3 times
Summary
This study will test whether a partially hydrolyzed whey protein formula can help ease mild allergy symptoms in infants. About 160 babies with mild skin, stomach, or breathing issues will be randomly assigned to get either the special formula or a standard cow's milk formula. Researchers will check if symptoms improve after two weeks and monitor safety and growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- partially hydrolyzed whey protein formula
- What this could lead to
- If it works, this could offer a gentle feeding option for infants with mild allergies, reducing skin and tummy symptoms.
- What could go wrong
- This is an early-stage study with only 160 infants, so results may not apply to all babies. The formula may not improve symptoms more than standard formula.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 20 weeks
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Infants aged ≥12 weeks and \<20 weeks at the time of screening. 2. Gestational age ≥37 weeks. 3. Birth weight ≥2500g. 4. Presence of mild allergic symptoms (e.g., skin, gastrointestinal, or respiratory symptoms). 5. Infants who are predominantly formula-fed or mixed-fed at the time of enrollment. 6. Legal guardian has provided written informed consent and agrees to participate in the study. Exclusion Criteria: 1. Diagnosed with moderate or severe food allergies, including a history of allergic conditions such as atopic dermatitis, wheezing bronchitis, or severe allergic reactions. 2. Confirmed cow's milk protein allergy. 3. Currently receiving a partially hydrolyzed formula or any other specialized formula. 4. Exclusively breastfed infants. 5. Known allergy or intolerance to the study formula. 6. Presence of severe illness (e.g., digestive, respiratory, neurological infections, other gastrointestinal diseases, gastrointestinal anatomical abnormalities, congenital malformations, or growth retardation). 7. Infants with a history of severe diseases such as heart, brain, liver, kidney, hematologic, connective tissue, endocrine diseases, or mental disorders. 8. Infants who have undergone major surgery that may impact the study outcomes. 9. Infants who have used systemic immune-modulating medications (e.g., anti-allergy drugs, corticosteroids, immunosuppressants, biological agents) within the last 2 weeks. 10. Infants who have used gastrointestinal medications (e.g., proton pump inhibitors, gastrointestinal motility agents, or digestive remedies) within the last 7 days. 11. Infants who have used probiotics within the last 7 days. 12. Parents who are unable to report the occurrence of symptoms or adhere to the study visits and protocol requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.