MedTrace Logo

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

NCT05481866 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2022-08-02

No results posted yet for this study

Summary

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.

Conditions

  • Gut Microbiota
  • Metabolites

Interventions

OTHER

Oropharyngeal administration of colostrum

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

OTHER

Oropharyngeal administration of sterile water

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

Sponsors & Collaborators

  • Shenzhen Bao'an Maternal and Child Health Hospital

    collaborator OTHER

  • Longgang Maternal and Child Health Hospital, Shenzhen, Guangdong

    collaborator UNKNOWN

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • Zhangbin Yu, PhD · Shenzhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05481866 on ClinicalTrials.gov