PrematurepremicNCT07558499
Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants
A study testing Rectal irrigation with maternal breast milk and Rectal irrigation with salin in people with Premature and Gut Microbiota Diversity and Composition, run by Zekai Tahir Burak Women's Health Research and Education Hospital.
Trial summary
This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants. Preterm infants are at increased risk of dysbiosis due to immaturity and limited enteral feeding in the early postnatal period. Read more about this study
- Who is it for?
- Ages 22 to 32 weeks
- Conditions the study is for
- Premature, Gut Microbiota Diversity and Composition, NEC - Necrotizing Enterocolitis
- What is being tested?
- Rectal irrigation with maternal breast milk and Rectal irrigation with salin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with a gestational age ≤32 weeks and birth weight ≤1500 g
- Infants without meconium passage within the first 48 hours of life
- Infants whose parents have provided written informed consent
Who cannot join
- nfants with major congenital anomalies
- Infants with gastrointestinal system anomalies
- Infants in whom administration of maternal breast milk is contraindicated
- Infants whose parents do not provide consent for participation
- Infants who die within the first 72 hours of life
About this study
Official title: Effect of Rectal Administration of Human Milk on Gut Microbiota and Clinical Outcomes in Preterm Infants: A Randomized Controlled Study
This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants. Preterm infants are at increased risk of dysbiosis due to immaturity and limited enteral feeding in the early postnatal period. In this randomized controlled study, preterm infants will receive either rectal administration of maternal breast milk or normal saline. The primary objective is to compare gut microbiota composition between the two groups. The findings may provide insight into a novel and non-invasive strategy to support microbiota development in preterm infants.
Read the detailed description
Preterm infants are highly vulnerable to alterations in gut microbiota due to immaturity, delayed enteral feeding, antibiotic exposure, and environmental factors. Early-life dysbiosis has been associated with adverse outcomes including necrotizing enterocolitis, sepsis, and impaired immune development. Strategies to promote healthy microbiota colonization in preterm infants are therefore of significant clinical interest.
Breast milk contains beneficial bacteria, prebiotics, and bioactive components that play a critical role in shaping neonatal gut microbiota. However, in the early postnatal period, especially in very preterm infants, enteral feeding may be limited or delayed. Alternative routes of exposure to breast milk components may offer a potential strategy to influence microbiota development.
This randomized controlled study aims to investigate the effects of rectal administration of maternal breast milk on gut microbiota in preterm infants. Participants will be randomly assigned to receive either rectal maternal breast milk or normal saline. Stool samples will be collected at predefined time points to assess microbiota composition.
The study is designed to explore whether rectal exposure to breast milk can modulate early microbial colonization and provide a feasible, safe, and innovative approach to support gut microbiota development in preterm infants.
- Being tested
- Rectal irrigation with maternal breast milk, Rectal irrigation with salin
- Keywords
- premature, gut microbiota, preterm morbidities
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal irrigation with maternal breast milkOther
Maternal breast milk will be used for rectal irrigation . Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.
Rectal irrigation with salinOther
Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed. Normal saline will be used for rectal irrigation as an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Rectal irrigation with maternal breast milk | Experimental | Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed. Maternal breast milk will be used for rectal irrigation. Receives: Other: Rectal irrigation with maternal breast milk |
| Rectal irrigation with normal saline | Active comparator | Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.Normal saline will be used for rectal irrigation as an active comparator. Receives: Other: Rectal irrigation with salin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition in preterm infants
Gut microbiota composition will be analyzed using stool samples collected from preterm infants at 7 days and 1 month of life, including assessment of microbial diversity and relative abundance of bacterial taxa, to evaluate differences between study groups.
Measured: 1 year
Secondary outcomes (3)
Time to full enteral feeding
Time to achieve full enteral feeding will be defined as the number of days from birth until the infant tolerates full enteral nutrition without the need for parenteral nutrition.
Measured: 1 year
Feeding intolerance
Feeding intolerance will be defined as the occurrence of bilious emesis, gastric residuals, visibly bloody stools, abdominal distension or tenderness, abdominal discoloration, gastric residual volume exceeding 50% of the previous feeding volume, emesis occurring three or more times within a 24-hour period, or clinical or radiological evidence of necrotizing enterocolitis (NEC).
Measured: 1 year
Necrotizing enterocolitis
Necrotizing enterocolitis will be diagnosed according to modified Bell's criteria stage II or higher.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a parallel design to one of two groups: rectal administration of maternal breast milk or rectal administration of normal saline. Outcomes will be compared between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Umraniye Education and Research Hospital, Kocaeli University
- Responsible party
- Principal investigator, Funda Yavanoglu Atay, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558499
- Sponsor's protocol ID
- PREMIC-2026
- Acronym
- premic
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rectal Administration of Human Milk on Gut Microbiota and Clinical Outcomes in Preterm Infants: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07558499
- Acronym / sponsor ID
- premic / PREMIC-2026
- Keywords
- premature, gut microbiota, preterm morbidities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Collaborators
- Umraniye Education and Research Hospital, Kocaeli University
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 30 Apr 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.
This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants. Preterm infants are at increased risk of dysbiosis due to immaturity and limited enteral feeding in the early postnatal period. In this randomized controlled study, preterm infants will receive either rectal administration of maternal breast milk or normal saline. The primary objective is to compare gut microbiota composition between the two groups. The findings may provide insight into a novel and non-invasive strategy to support microbiota development in preterm infants.
Detailed description
Preterm infants are highly vulnerable to alterations in gut microbiota due to immaturity, delayed enteral feeding, antibiotic exposure, and environmental factors. Early-life dysbiosis has been associated with adverse outcomes including necrotizing enterocolitis, sepsis, and impaired immune development. Strategies to promote healthy microbiota colonization in preterm infants are therefore of significant clinical interest.
Breast milk contains beneficial bacteria, prebiotics, and bioactive components that play a critical role in shaping neonatal gut microbiota. However, in the early postnatal period, especially in very preterm infants, enteral feeding may be limited or delayed. Alternative routes of exposure to breast milk components may offer a potential strategy to influence microbiota development.
This randomized controlled study aims to investigate the effects of rectal administration of maternal breast milk on gut microbiota in preterm infants. Participants will be randomly assigned to receive either rectal maternal breast milk or normal saline. Stool samples will be collected at predefined time points to assess microbiota composition.
The study is designed to explore whether rectal exposure to breast milk can modulate early microbial colonization and provide a feasible, safe, and innovative approach to support gut microbiota development in preterm infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a parallel design to one of two groups: rectal administration of maternal breast milk or rectal administration of normal saline. Outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Rectal irrigation with maternal breast milk | Experimental | Other: Rectal irrigation with maternal breast milkRectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed. Maternal breast milk will be used for rectal irrigation. |
| Rectal irrigation with normal saline | Active comparator | Other: Rectal irrigation with salinRectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.Normal saline will be used for rectal irrigation as an active comparator. |
Who may qualify
- Ages
- 22 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants with a gestational age ≤32 weeks and birth weight ≤1500 g
- Infants without meconium passage within the first 48 hours of life
- Infants whose parents have provided written informed consent
Key exclusion criteria (5 listed)
- nfants with major congenital anomalies
- Infants with gastrointestinal system anomalies
- Infants in whom administration of maternal breast milk is contraindicated
- Infants whose parents do not provide consent for participation
- Infants who die within the first 72 hours of life
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 |
|---|---|---|
| Rectal irrigation with maternal breast milkMaternal breast milk will be used for rectal irrigation . Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed. | Other | Rectal irrigation with maternal breast milk |
| Rectal irrigation with salinRectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00. A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used. The enema volume will be calculated as 5 mL/kg and warmed to 37°C. One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication. The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed. Normal saline will be used for rectal irrigation as an active comparator. | Other | Rectal irrigation with normal saline |
Primary outcome
Gut microbiota composition in preterm infants
Time frame: 1 year
Gut microbiota composition will be analyzed using stool samples collected from preterm infants at 7 days and 1 month of life, including assessment of microbial diversity and relative abundance of bacterial taxa, to evaluate differences between study groups.
3 secondary outcomes
Time to full enteral feeding
Time frame: 1 year
Feeding intolerance
Time frame: 1 year
Necrotizing enterocolitis
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal irrigation with maternal breast milk and Rectal irrigation with salin in people with Premature and Gut Microbiota Diversity and Composition, run by Zekai Tahir Burak Women's Health Research and Education Hospital.
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 5 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: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Gut microbiota composition in preterm infants (time frame: 1 year). 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 30 Apr 2026.