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

NCT06118801 | Unknown

• 1 other identifier: HarrranU-FSolmaz-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (8)

• Necrotizan Enterocolit (NEC)

  Preterm baby diagnosed with NEC(Whether or not NEC was diagnosed as stage 2 or higher according to Bell staging)

  4 months

• Late Onset Sepsis(LOS)

  Preterm baby diagnosed with LOS(whether they have been diagnosed with sepsis confirmed by a positive blood culture

  4 months

• head circumference measurement

  head circumference measurement of preterm baby(Change in head circumference to be measured weekly (in centimeters))

  4 months

• weight measurement of preterm baby

  Weight measurement of the premature baby (weight measurement will be measured weekly (in grams))

  4 months

• Hyperbilirubinemia

  measuring total bilirubin level on the 1st and 5th day of birth

  4 months

• Phototherapy

  How many hours of phototherapy the baby received during hospitalization

  4 months

• Full oral Feeding

  Time for the preterm baby to transition to full oral feeding

  4 months

• Hospitalization Day

  Hospitalization period (in days)

  4 months

Study Arms (2)

Probiotic group

EXPERIMENTAL

Mothers of premature babies in this group will be given breast milk and breastfeeding training immediately after birth in order to ensure that they can give only breast milk to their babies, and at the same time, 80 ml of probiotic supplements will be given once a day for 20 days.

Dietary Supplement: Probiotic Product Supplement

control group

NO INTERVENTION

There will be no intervention for mothers of preterm babies in this group, and they will be trained on breast milk and breastfeeding so that they can give only breast milk to the baby.

Interventions

Probiotic Product Supplement DIETARY_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)

Probiotic group

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being 18 years or older
• Having the ability to read, write and understand Turkish,
• Having a singleton pregnancy,
• Birth time is between 28-32 weeks of gestation,
• Not being a smoker
• Being able to breastfeed your baby at least 8-10 times a day
• The mother does not have any diagnosed digestive system disease (ulcerative colitis, Crohn's disease, etc.) (This information will be obtained from the mother's file)
• Volunteering to participate in the research
• The baby's gestational age is between 28-32 weeks (including the 28th and 32nd weeks)

You may not qualify if:

• The mother has problems with expressing milk or breast problems,
• The mother has a chronic disease (pre-existing clinical conditions such as diabetes, hypertension, hypothyroidism, autoimmune diseases, asthma, allergy, kidney or liver diseases, viral, bacterial or protozoan infection, anemia (hemoglobin, Hb\<0 g/L), etc.). to be
• The mother is using another probiotic product
• The mother does not use the recommended probiotic appropriately and at the appropriate time.
• Giving breast milk to the baby less than 8 times for 2 consecutive days,
• The sampled mother is also included in other clinical studies.
• The baby uses formula other than breast milk for more than 24 hours
• The baby has a health problem that prevents breastfeeding
• Presence of genetic and metabolic disease in the baby,
• Congenital anomaly in the baby,
• Presence of neurological, gastrointestinal or major cardiac anomalies and/or hypoxic brain damage.

Sponsors & Collaborators

• Harran University: lead
• Hasan Kalyoncu University: collaborator

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing; Neonatal Sepsis; Breast Milk Expression

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; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Breast Feeding; Feeding Behavior; Behavior

Study Officials

• Alev Esercan

  https://sanliurfaeah.saglik.gov.tr/

  STUDY CHAIR

Central Study Contacts

Filiz Solmaz

CONTACT

+90 414 318 3203; filizsolmaz@harran.edu.tr

Zerrin Çiğdem

CONTACT

+905324352243; zerrinogrenci@gmail.com

Study Design

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

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11