Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum

Southern University of Science and Technology

Status: Not yet enrolling

Conditions: Gut Microbiota; Metabolites

Treatments: Other: Oropharyngeal administration of colostrum; Other: Oropharyngeal administration of sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT05481866

SZPH-2022-52

Details and patient eligibility

About

Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract. However, how OAC promotes intestinal maturation in preterm infants by altering the gut microbiota remains unclear. We aim to assess the changes of gut microbiota and metabolites after OAC in very preterm infants.

Methods: A multicenter, double-blind, randomized controlled trial will be conducted in 3 large NICUs in Shenzhen, China, for preterm infants with gestational age less than 32 weeks and birth weight less than 1500g. The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days; The control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above. Stool samples will be collected at the first defecation and the 7th day after birth. It is estimated that 320 preterm infants will participate in the study within 1 year. 16sRNA gene sequencing and liquid chromatography-mass spectrometry will be used to analyze the effect of OAC on gut microbiota and metabolites.

Discussion: The proposal advocates for the promotion of OAC as a safe and relatively beneficial initiative among neonatal intensive care units, and this initiative may contribute to the establishment of a dominant intestinal flora. Findings of this study may help to improve the health outcomes of preterm infants by constructing targeted gut microbiota in future studies.

Full description

Preterm infants with gestational age < 32 weeks and weight < 1500g will be evaluated. Infants who met the inclusion criteria will be randomly divided into two groups according to the ratio of 1:1. The intervention group will be given oropharyngeal colostrum every 3 hours for 5 days; the control group will be given sterile water with the same dosage and administration scheme. Stool samples will be collected at the first defecation and the 7th day to detect the gut microbiota and metabolites.

Enrollment: 320 estimated patients

Sex: All

Ages: Under 32 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• gestational age less than 32 weeks and birth weight less than 1500g;
• admission to NICU ≤ 24 hours;
• be able to start the agreement within 72 hours of birth.

Exclusion criteria

• birth asphyxia (defined as umbilical artery / first hour arterial PH < 7.0 or cardiopulmonary resuscitation in the delivery room);
• birth complicated with severe gastrointestinal malformations (such as intestinal atresia, esophago-tracheal fistula, intestinal rotation abnormalities, congenital megacolon);
• prenatal diagnosis of congenital chromosomal abnormalities or suspected congenital genetic metabolic diseases;
• maternal drug abuse or contraindications to breastfeeding (HIV and cytomegalovirus infection).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups, including a placebo group

The intervention group will be given colostrum for oropharyngeal administration

Experimental group

Description:

The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days.

Treatment:

Other: Oropharyngeal administration of colostrum

The control group will be given sterile water for oropharyngeal administration

Placebo Comparator group

Description:

The control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above.

Treatment:

Other: Oropharyngeal administration of sterile water