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IRCT20171218037936N4 IRCT 2025-10-08 Oroumia University of Medical Sciences Studying the effect of probiotics on intestinal colonization of pathogenic bacteria and Candida in very low birth weight premature infants admitted to the neonatal intensive care unit PP-VLBW Studying the effect of probiotics on intestinal colonization of pathogenic bacteria and Candida in very low birth weight premature infants admitted to the neonatal intensive care unit. 2025-10-23 anticipated 130 Complete https://irct.ir/trial/86609 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization in this study will be carried out using a computer-generated random number sequence created in Microsoft Excel (version …), which will be executed by a research assistant not involved in participant recruitment or clinical care to ensure allocation concealment. Acknowledging the type of feeding as a significant and influential variable, the randomization process will be stratified based on two distinct strata: 'breastfed infants' and 'formula-fed infants'. Within each of these feeding strata, infants will be randomly allocated in a 1:1 ratio to either the intervention group, receiving the probiotic supplement, or the control group, receiving a placebo. This stratified randomization approach ensures a balanced distribution of infants with different feeding patterns across both study groups, thereby enabling a robust and valid comparison of the probiotic's effect. N/A Intestinal Colonization by multidrug-resistant organisms and Candida species.. Intervention 1: Intervention group: The probiotic group, which includes two subgroups of breastfed infants and formula-fed infants, will be assigned. From the start of feeding, five drops of probiotic Lactobacillus reuteri (Procid) will be given to the infants daily for 5 days.On the sixth day, the newborn's stool will be collected and sent to the laboratory of Shahid Motahari Hospital in Urmia for culture and stool examination. Intervention 2: Control group: Includes two subgroups of breastfed infants and formula-fed infants. On the sixth day, the infants' stool will be collected and sent to the laboratory of Shahid Motahari Hospital in Urmia for culture and stool exam. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Kamran Dehghan
No. 8, 2nd alley, Adalat Ave., orumieh city
Orumieh Iran (Islamic Republic of) 5716114819 +98 44 3365 4154 dehghan.k@umsu.ac.ir Oroumia University of Medical Sciences scientific Kamran Dehghan
No. 8, 2nd alley, Adalat Ave., orumieh city
Orumieh Iran (Islamic Republic of) 5716114819 +98 44 3365 4154 dehghan.k@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Premature, low birth weight (birth weight between 1000 and 1500 grams) Gestational age less than 32 weeks Admission to the neonatal intensive care unit (NICU) within the first 72 hours of life no limit 3 days Both Dissatisfaction of the patient's parents Infant with digestive disorders after entering the study (intestinal obstruction, severe digestive diseases, etc.) Drug allergy Mortality A04.9 Bacterial intestinal infection, unspecified Prevention Prevention Intervention group: The probiotic group, which includes two subgroups of breastfed infants and formula-fed infants, will be assigned. From the start of feeding, five drops of probiotic Lactobacillus reuteri (Procid) will be given to the infants daily for 5 days.On the sixth day, the newborn's stool will be collected and sent to the laboratory of Shahid Motahari Hospital in Urmia for culture and stool examination. Control group: Includes two subgroups of breastfed infants and formula-fed infants. On the sixth day, the infants' stool will be collected and sent to the laboratory of Shahid Motahari Hospital in Urmia for culture and stool exam. Rate of intestinal colonization with pathogenic bacteria based on stool culture. Timepoint: Day 6 after the start of the intervention. Method of measurement: Microbiological culture of stool sample. Results of the Stool Exam. Timepoint: Day 6 after the start of the intervention. Method of measurement: Direct microscopic examination of the stool sample. Oroumia University of Medical Sciences Approved 2025-09-24 Ethic committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Orzhans Alley, Resalat St. ,Urmia , Iran Urmia West Azarbaijan Iran (Islamic Republic of)