The Effect of Probiotics Added to the Mother's Diet on Preterm Babies

Summary

Abstract According to the definition by World Health Organization; births before the completion of the 37th gestational week are called, preterm birth. Preterm birth is among the most important causes of mortality and morbidity during infancy. Necrotizing enterocolitis (NEC) is the most common gastrointestinal emergency encountered in the Neonatal Intensive Care Unit. The most common risk factors are, preterm birth, enteral feeding and bacterial colonization.

Late Onset Sepsis (LOS) is one of the most common causes of morbidity and mortality in the preterm infants. A healthy gut microbiota has a key role in developing and maintaining a balanced immune response and establishing the intestinal barrier in the immediate postnatal period. Probiotics come to the fore as means that may be effective in preventing NEC and LOS.

Although it is widely accepted that, breast milk has its own microbiota, the origin of these bacterial populations in the milk, has not been fully understood. The new information regarding especially the anaerobic species associated with the intestinal environments that cannot be found in the aerobic environments, suggests an endogenous route to the mammary gland through the presence of the entero-mammary pathway.

The aim of this project is to determine the effect of the probiotics added to the maternal diet on the incidence of encountering NEC and LOS in the preterm infants. The unique value of this project is that, 80 ml of probiotic yogurt will be given to mothers of the preterm infants, who still breastfeed their babies, for 20 days and the effects on the baby will be examined in the scope of the study.

The study has been planned to be conducted as a randomized controlled study in the Neonatal Intensive Care Unit of Şanlıurfa Training and Research Hospital. The power analysis was performed with G\*Power for the sample size of the study, which has an experimental/control design structure. The sample size was determined as 50 in total. Data collection tools were organized as Mother and Infant Introductory Information Form (23 questions), Mother and Infant Follow-up Form during Probiotic Implementation (7 questions). At the beginning of the study, all mothers will fill out the mother and baby introductory information form, and the mothers in the experimental group will be given 80 ml probiotic yogurt support once a day for 20 days. In addition to that, all the babies will be monitored for growth once a week, throughout the process. Their status of regular breastfeeding, whether they are diagnosed with NEC and LOS, the time of transition to oral feeding, their bilirubin levels, their status of receiving phototherapy and their discharge durations will be evaluated, and a questionnaire that consists of scale questions will be applied after the discharge.

As a result of this project, it is aimed with the probiotic that will be added to maternal nutrition to reduce the encounter of NEC and LOS in preterm infants, to positively affect the intestinal microbiota by preventing dysbiosis in these infants, to protect them from very important problems such as NEC and LOS as well as accelerating the transition to oral feeding, to help them gain weight, to shorten the duration of receiving phototherapy and hospitalization by reducing the bilirubin levels.

Conditions

• Preterm
• Necrotizing Enterocolitis
• Late-Onset Neonatal Sepsis
• Breast Milk Expression

Interventions

DIETARY_SUPPLEMENT

Probiotic Product Supplement

Mothers of preterm babies who feed their babies only with breast milk will be given a probiotic product supplement once a day (80 ml probiotic product support containing the Actregularis (5×106 CFU\\mL) (lactobacillus bulgaricus, streptococcus thermophilus, lactococcus lactis and bifidobacterium lactis) strain)

Sponsors & Collaborators

• Hasan Kalyoncu University

  collaborator OTHER

• Harran University

  lead OTHER

Principal Investigators

• Alev Esercan · https://sanliurfaeah.saglik.gov.tr/

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

28 Weeks

Max Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-30

Primary Completion

2024-02-29

Completion

2024-03-31