Status:

UNKNOWN

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

Lead Sponsor:

Harran University

Collaborating Sponsors:

Hasan Kalyoncu University

Conditions:

Preterm

Necrotizing Enterocolitis

Eligibility:

All Genders

28-32 years

Phase:

NA

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...

Detailed Description

Preterm birth is birth that occurs before the completion of the 37th week of pregnancy. It affects approximately 10% of pregnancies and is a leading cause of perinatal morbidity and mortality. Preterm...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for Mothers;
  • 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
  • Inclusion Criteria for Babies:
  • • The baby's gestational age is between 28-32 weeks (including the 28th and 32nd weeks)

Exclusion

  • Exclusion Criteria for Mothers from the Study;
  • 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.
  • Exclusion Criteria for Babies from the Study;
  • 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.

Key Trial Info

Start Date :

November 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2024

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06118801

Start Date

November 1 2023

End Date

March 1 2024

Last Update

November 7 2023

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