Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants

NCT07558499 | Not Yet Recruiting

• 1 other identifier: PREMIC-2026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature; Gut Microbiota Diversity and Composition; NEC - Necrotizing Enterocolitis

Keywords

premature; gut microbiota; preterm morbidities

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Time to full enteral feeding

  1 year

• Feeding intolerance

  1 year

• Necrotizing enterocolitis

  1 year

Study Arms (2)

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.

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.

Other: Rectal irrigation with salin

Interventions

Rectal irrigation with maternal breast milk OTHER

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 maternal breast milk

Rectal irrigation with salin OTHER

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.

Rectal irrigation with normal saline

Eligibility Criteria

• Age: 22 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: collaborator
• Kocaeli University: collaborator
• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-03