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Search / Trial NCT06118801

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

Launched by HARRAN UNIVERSITY · Nov 1, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how adding probiotics, which are beneficial bacteria, to a mother’s diet can help improve the health of preterm babies. Preterm babies, born before 37 weeks of pregnancy, are at higher risk for serious conditions like necrotizing enterocolitis (NEC) and late-onset sepsis (LOS). The researchers want to see if giving mothers 80 ml of probiotic yogurt daily for 20 days can lower the chances of their babies developing these conditions and improve their overall health, including faster weight gain and shorter hospital stays.

To participate in this study, mothers must be 18 or older, able to breastfeed their baby at least 8-10 times a day, and have a single baby born between 28 and 32 weeks of pregnancy. Babies in the study must also be within that same gestational age range. Throughout the trial, mothers will complete some simple questionnaires, and both mothers and babies will be monitored for health and growth. This study aims to provide valuable information about the role of probiotics in supporting the health of preterm infants.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About Harran University

Harran University is a distinguished academic institution committed to advancing healthcare through innovative research and clinical trials. With a focus on enhancing patient outcomes, the university leverages its multidisciplinary expertise to conduct rigorous scientific investigations. Harran University fosters collaboration among researchers, clinicians, and industry partners to explore novel therapeutic approaches and improve clinical practices. Through its dedication to ethical standards and patient safety, Harran University aims to contribute significantly to the body of medical knowledge and the development of effective treatments.

Locations

Patients applied

0 patients applied

Trial Officials

Alev Esercan

Study Chair

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported