Can a digestive enzyme help premature babies tolerate milk?
NCT ID NCT07784062
First seen Aug 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This trial tests whether adding lactase enzyme to milk feeds helps preterm infants digest lactose and reduce feeding intolerance—a common problem in babies born before 34 weeks. Eligible infants are randomly assigned to receive either lactase-treated feeds or a placebo, and researchers compare signs like stomach residual volume, abdominal distension, vomiting, and diarrhea. The goal is to see if lactase supplementation supports better feeding progression and growth in these vulnerable newborns.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lactase enzyme added to milk feeds
- What this could lead to
- If effective, lactase-treated feeds could become a simple, low-cost way to help preterm infants tolerate feeding better, potentially reducing hospital stays and improving growth.
- What could go wrong
- This is a small, early-stage trial, so results may not apply broadly. Lactase may not significantly improve symptoms, and there is always a risk of unexpected side effects in fragile preterm infants.
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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70 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Jun 2026
- 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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0 to 28 days
- 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 * Gestational age \<34 weeks. * ≥2 symptoms suggestive of lactose intolerance: abdominal distension, abdominal pain, diarrhea, or diaper/nappy dermatitis. * Feeding intolerance defined by GRV \>3 mL/kg or the specified vomiting/stool/abdominal-distension. Exclusion Criteria: * Severe congenital malformations, including GI or cardiac defects. * NEC according to Bell's staging criteria. * Congenital diarrhea. * Hemodynamic instability requiring inotropes. * Amino-acid-based or lactose-free formula. * Guardian declines consent.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NICU of Ain shams university hospitals
Cairo, Cairo Governorate, 02, Egypt