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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gut Microbiota Metabolites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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The intervention group will be given colostrum for oropharyngeal administration

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.

Group Type EXPERIMENTAL

Oropharyngeal administration of colostrum

Intervention Type OTHER

The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours.

The control group will be given sterile water for oropharyngeal administration

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

Group Type PLACEBO_COMPARATOR

Oropharyngeal administration of sterile water

Intervention Type OTHER

The control group will be given 0.2ml sterile water for oropharyngeal administration every 3 hours.

Interventions

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Oropharyngeal administration of colostrum

The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours.

Intervention Type OTHER

Oropharyngeal administration of sterile water

The control group will be given 0.2ml sterile water for oropharyngeal administration every 3 hours.

Intervention Type OTHER

Eligibility Criteria

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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).

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes