Skip to content

Efficacy and safety of Lactase Drops in the Treatment of Lactose Intolerance in Premature Infants: a prospective, multi-center, randomized controlled trial

Efficacy and safety of Lactase Drops in the Treatment of Lactose Intolerance in Premature Infants: a prospective, multi-center, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106142
Enrollment
Unknown
Registered
2025-07-18
Start date
2025-07-18
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infants Lactose Intolerance

Interventions

Lactase group:Add lactase to milk
Lactose-free group:Use lactose-free formula feeding
Control group:None

Sponsors

First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preterm infants who have already been fed enterally (neonates born with a gestational age of = 0.25% or fecal pH <=5.5. 3. Informed consent from the patient's family. 4. Control group neonates (including preterm and term infants): Neonates who have already been fed enterally, with no restrictions on gender or gestational age. 5. Control group neonates (including preterm and term infants): Neonates who have not been fed with lactose-free formula or low-lactose formula before the study.

Exclusion criteria

Exclusion criteria: 1. Infants with congenital malformations or congenital metabolic diseases; infants with neonatal asphyxia (Apgar score <=7). 2. Preterm infants with a confirmed diagnosis of cow's milk protein allergy. 3. Preterm infants who are unable to be fed enterally. 4. Mothers of the infants had specific diseases during pregnancy. 5. Families unwilling to sign the informed consent form and refusing to participate in this study. 6. Control group neonates (including preterm and term infants): Infants with cardiovascular, urinary, digestive, nervous, endocrine, congenital diseases, and acute or chronic infectious diseases. 7. Control group neonates (including preterm and term infants): Families of the infants refuse to participate in this project. 8. Control group neonates (including preterm and term infants): Infants diagnosed with neonatal lactose intolerance.

Design outcomes

Primary

MeasureTime frame
CR Rate;PR Rate;OR Rate;AE Rate;

Secondary

MeasureTime frame
Changes in oral microecology;Changes in the intestinal microecology;Changes in metabolomics of blood and urine ;The influence on growth and development;

Countries

China

Contacts

Public ContactYu Muxue

First Affiliated Hospital of Sun Yat-sen University

yumuxue@163.com+86 189 2885 7818

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026