Feeding Intolerance in Preterm InfantsNCT07784062
The Effect of Lactase-Treated Feeds on Feeding Intolerance in Preterm Infants
A study testing Lactase enzyme and Distilled water in people with Feeding Intolerance in Preterm Infants, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate whether adding lactase enzyme to milk feeds can improve feeding tolerance in preterm neonates. Preterm infants may have immature gastrointestinal function and reduced intestinal lactase activity, which may contribute to difficulty digesting lactose and symptoms of feeding… Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Feeding Intolerance in Preterm Infants
- What is being tested?
- Lactase enzyme and Distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2025to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate whether adding lactase enzyme to milk feeds can improve feeding tolerance in preterm neonates. Preterm infants may have immature gastrointestinal function and reduced intestinal lactase activity, which may contribute to difficulty digesting lactose and symptoms of feeding intolerance. In this study, eligible preterm neonates will be randomly assigned to receive either lactase-treated milk feeds or placebo-treated milk feeds. Feeding tolerance will be assessed using clinical and nutritional parameters during the study period. The study will compare the two groups to determine whether lactase supplementation improves feeding tolerance and supports better progression of enteral feeding in preterm neonates. The hypothesis is that lactase-treated feeds will reduce feeding intolerance and facilitate achievement of adequate enteral feeding compared with placebo.
Read the detailed description
This is a randomized, controlled, parallel-group interventional study designed to evaluate the effect of lactase-treated feeds on feeding intolerance in preterm neonates.
Preterm neonates are at increased risk of feeding intolerance because of gastrointestinal immaturity, delayed gastric emptying, immature intestinal motility, and incomplete development of digestive enzyme activity. Lactase activity may be relatively low in preterm infants, potentially resulting in incomplete lactose digestion and contributing to gastrointestinal symptoms associated with feeding intolerance.
Eligible preterm neonates will be enrolled according to predefined inclusion and exclusion criteria. Participants will be randomly allocated into two groups. The intervention group will receive milk feeds treated with lactase enzyme, while the control group will receive milk feeds treated with placebo. The placebo will consist of distilled water administered in an equivalent manner to the lactase preparation.
The study will evaluate feeding tolerance throughout the study period. Clinical parameters related to feeding tolerance will be recorded, including the occurrence and severity of feeding intolerance manifestations and the progression of enteral feeding. Nutritional and growth-related parameters will also be assessed according to the study protocol.
The primary objective is to determine whether lactase-treated feeds improve feeding tolerance in preterm neonates compared with placebo-treated feeds. Secondary objectives include evaluating the effect of lactase supplementation on the progression of enteral feeding and selected nutritional and growth outcomes.
The study is expected to provide evidence regarding whether exogenous lactase supplementation may be beneficial in preterm neonates experiencing feeding intolerance
- Conditions
- Feeding Intolerance in Preterm Infants
- Being tested
- Lactase enzyme, Distilled water
- Keywords
- Feeding intolerance Preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactase enzymeDrug
Lactase enzyme treated feeds
Distilled waterOther
Distilled water administered as placebo to the control group during enteral feeding.
| Study group | Role | What they receive |
|---|---|---|
| Lacrase treated feeds | Experimental | Preterm neonates randomly assigned to this group will receive enteral feeds treated with lactase enzyme Receives: Drug: Lactase enzyme |
| Placebo | Placebo comparator | Preterm neonates randomly assigned to the control group will receive enteral feeds treated with an equivalent volume of sterile distilled water as placebo. Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in gastric residual volume
Gastric residual volume measured in milliliters before feeding and serially during the intervention period. The outcome will be assessed by comparing the change in gastric residual volume from baseline between the lactase-treated feed group and the placebo group.
Measured: From start of intervention till 2 weeks
Number of participants with abdominal distension
Abdominal distension assessed clinically by serial abdominal examination and abdominal circumference measurement during the intervention period. Participants with clinically evident abdominal distension will be recorded.
Measured: From initiation of intervention to 2weeks
Number of participants with vomiting
Vomiting episodes will be assessed by clinical observation during the intervention period and recorded for each participant.
Measured: From initiation of intervention to 2 weeks
Number of participants with diarrhea
Diarrhea will be assessed clinically according to stool frequency and consistency during the intervention period and recorded for each participant.
Measured: From initiation of intervention to 2 weeks
Secondary outcomes (4)
Mean change from baseline in body length
Body length measured in centimeters using a standardized infant length board. Length will be assessed at baseline and at the end of the intervention period.
Measured: From initiation of the study intervention till 2 weeks
Mean change from baseline in body weight
Body weight measured in grams using a calibrated neonatal weighing scale. Weight will be measured serially during the study period and the change from baseline will be compared between the lactase-treated feed group and the placebo group.
Measured: From initiation of intervention to 2 weeks
Mean change from baseline in head circumference
Head circumference measured in centimeters using a non-stretchable measuring tape placed around the largest occipital-frontal circumference. Measurements will be obtained at baseline and at the end of the intervention period.
Measured: From initiation of intervention to 2 weeks
Mean change from baseline in mid-upper arm circumference
Mid-upper arm circumference measured in centimeters using a non-stretchable measuring tape at the midpoint of the upper arm. Measurements will be obtained at baseline and at the end of the intervention period.
Measured: From initiation of intervention to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Nov 2025
- Primary completion30 Nov 2025
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding Intolerance in Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel study groups. The intervention group will receive lactase-treated feeds, while the control group will receive placebo (distilled water) administered according to the study protocol. Participants will be followed prospectively to compare feeding tolerance and related clinical outcomes between the two groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ola Galal, Study director, NICU of Ain shams university hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784062
- Sponsor's protocol ID
- ASU-PED-LACT-001
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactase-Treated Feeds on Feeding Intolerance in Preterm Infants
- ClinicalTrials.gov ID
- NCT07784062
- Acronym / sponsor ID
- ASU-PED-LACT-001
- Conditions
- Feeding Intolerance in Preterm Infants
- Keywords
- Feeding intolerance Preterm infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether adding lactase enzyme to milk feeds can improve feeding tolerance in preterm neonates. Preterm infants may have immature gastrointestinal function and reduced intestinal lactase activity, which may contribute to difficulty digesting lactose and symptoms of feeding intolerance. In this study, eligible preterm neonates will be randomly assigned to receive either lactase-treated milk feeds or placebo-treated milk feeds. Feeding tolerance will be assessed using clinical and nutritional parameters during the study period. The study will compare the two groups to determine whether lactase supplementation improves feeding tolerance and supports better progression of enteral feeding in preterm neonates. The hypothesis is that lactase-treated feeds will reduce feeding intolerance and facilitate achievement of adequate enteral feeding compared with placebo.
Detailed description
This is a randomized, controlled, parallel-group interventional study designed to evaluate the effect of lactase-treated feeds on feeding intolerance in preterm neonates.
Preterm neonates are at increased risk of feeding intolerance because of gastrointestinal immaturity, delayed gastric emptying, immature intestinal motility, and incomplete development of digestive enzyme activity. Lactase activity may be relatively low in preterm infants, potentially resulting in incomplete lactose digestion and contributing to gastrointestinal symptoms associated with feeding intolerance.
Eligible preterm neonates will be enrolled according to predefined inclusion and exclusion criteria. Participants will be randomly allocated into two groups. The intervention group will receive milk feeds treated with lactase enzyme, while the control group will receive milk feeds treated with placebo. The placebo will consist of distilled water administered in an equivalent manner to the lactase preparation.
The study will evaluate feeding tolerance throughout the study period. Clinical parameters related to feeding tolerance will be recorded, including the occurrence and severity of feeding intolerance manifestations and the progression of enteral feeding. Nutritional and growth-related parameters will also be assessed according to the study protocol.
The primary objective is to determine whether lactase-treated feeds improve feeding tolerance in preterm neonates compared with placebo-treated feeds. Secondary objectives include evaluating the effect of lactase supplementation on the progression of enteral feeding and selected nutritional and growth outcomes.
The study is expected to provide evidence regarding whether exogenous lactase supplementation may be beneficial in preterm neonates experiencing feeding intolerance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel study groups. The intervention group will receive lactase-treated feeds, while the control group will receive placebo (distilled water) administered according to the study protocol. Participants will be followed prospectively to compare feeding tolerance and related clinical outcomes between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Lacrase treated feeds | Experimental | Drug: Lactase enzymePreterm neonates randomly assigned to this group will receive enteral feeds treated with lactase enzyme |
| Placebo | Placebo comparator | Other: Distilled waterPreterm neonates randomly assigned to the control group will receive enteral feeds treated with an equivalent volume of sterile distilled water as placebo. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactase enzymeLactase enzyme treated feeds | Drug | Lacrase treated feeds |
| Distilled waterDistilled water administered as placebo to the control group during enteral feeding. | Other | Placebo |
Primary outcome
Mean change from baseline in gastric residual volume
Time frame: From start of intervention till 2 weeks
Gastric residual volume measured in milliliters before feeding and serially during the intervention period. The outcome will be assessed by comparing the change in gastric residual volume from baseline between the lactase-treated feed group and the placebo group.
Number of participants with abdominal distension
Time frame: From initiation of intervention to 2weeks
Abdominal distension assessed clinically by serial abdominal examination and abdominal circumference measurement during the intervention period. Participants with clinically evident abdominal distension will be recorded.
Number of participants with vomiting
Time frame: From initiation of intervention to 2 weeks
Vomiting episodes will be assessed by clinical observation during the intervention period and recorded for each participant.
Number of participants with diarrhea
Time frame: From initiation of intervention to 2 weeks
Diarrhea will be assessed clinically according to stool frequency and consistency during the intervention period and recorded for each participant.
4 secondary outcomes
Mean change from baseline in body length
Time frame: From initiation of the study intervention till 2 weeks
Mean change from baseline in body weight
Time frame: From initiation of intervention to 2 weeks
Mean change from baseline in head circumference
Time frame: From initiation of intervention to 2 weeks
Mean change from baseline in mid-upper arm circumference
Time frame: From initiation of intervention to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Feeding Intolerance in Preterm Infants
Active, not recruiting
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Prematurity, Light-For-Dates
Enrolling by invitation
Abdominal Binders to Minimize Enteral Nutrition Disruptions for Preterm Infants On Non-Invasive Respiratory Support
Feeding Intolerance, Abdominal Distension
Recruiting
Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
Bronchopulmonary Dysplasia, Feeding Intolerance
Not yet recruitingObservational study
Feeding Intolerance in Preterm Infant
Feeding Intolernce
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola Galal study director
NICU of Ain shams university hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactase enzyme and Distilled water in people with Feeding Intolerance in Preterm Infants, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in gastric residual volume (time frame: From start of intervention till 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.