Gut Microbiota Diversity and Composition, NEC - Necrotizing Enterocolitis, Premature
Conditions
Keywords
premature, gut microbiota, preterm morbidities
Brief 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. 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.
Interventions
OTHERRectal irrigation with maternal breast milk
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.
OTHERRectal irrigation with salin
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.
Sponsors
Zekai Tahir Burak Women's Health Research and Education Hospital
Umraniye Education and Research Hospital
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessors analyzing microbiota data will be blinded to group allocation. Care providers and investigators will not be blinded due to the nature of the intervention.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition in preterm infants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to full enteral feeding | 1 year | 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. |
| Feeding intolerance | 1 year | 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). |
| Necrotizing enterocolitis | 1 year | Necrotizing enterocolitis will be diagnosed according to modified Bell's criteria stage II or higher. |
Outcome results
None listed