Status:
RECRUITING
Lactase-Assisted Control Trial On Weight GAin in INfants.
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Premature - Weight 1000g-2499g or Gestation of 28-37weeks
Healthy
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
Lactose, a disaccharide that includes the monosaccharides glucose and galactose, is the main carbohydrate found exclusively in mammalian milk. Lactase is found in the intestinal mucosa and is located ...
Detailed Description
Lactose, a disaccharide that includes the monosaccharides glucose and galactose, is the main carbohydrate found exclusively in mammalian milk. The absorption of lactose requires lactase activity to br...
Eligibility Criteria
Inclusion
- The study will enrol newborns (1) with a gestational duration of 28 to 34 weeks, (2) who receive ≥75% of their energy needs intestinally, (3) with the absence of severe congenital malformations or gastrointestinal diseases, including necrotizing enterocolitis (NEC) (4) without taking postnatal steroids or diuretics. Small, suitable and large for newborns of gestational age will be eligible for the study.
Exclusion
- Exclusion criteria will be neonates whose guardians refuse to participate in the study, neonates with congenital malformations or gastrointestinal diseases, and neonates receiving postnatal steroids or diuretics.
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07150884
Start Date
August 27 2025
End Date
August 1 2027
Last Update
September 11 2025
Active Locations (2)
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1
Papageorgiou General Hospital
Thessaloniki, Greece
2
Papageorgiou General Hospital
Thessaloniki, Greece