]>
IRCT20130812014333N175 IRCT 2021-09-25 Kermanshah University of Medical Sciences the effect of concomitant use of Lactobacillus Ramnosus probiotic and oral antifungal nystatin on inhibitory intestinal colony growth in Candida albicans in infants under 2500 g Comparative study of the effect of concomitant use of Lactobacillus Ramnosus probiotic and oral antifungal nystatin on inhibitory intestinal colony growth in Candida albicans in infants under 2500 g 2021-10-02 anticipated 100 Complete https://irct.ir/trial/58545 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For random allocation, permuted block randomization method is used to balance the number of samples assigned to each of the study groups. This method is done by selecting blocks with the size of each quadruple block (2 participants in the intervention group and 2 participants in the control group) and each of the 6 possible cases of numbers for the quad block is assigned as follows: 1) AABB 2) ABAB 3) ABBA 4) BBAA 5) BABA 6) BAAB. Using a table of random numbers, the numbers between 1 and 6 are selected and in accordance with each number, the allocation list of the intervention or control group will be determined, thus sampling will continue until the end of the samples, Blinding description: In this study, participants and statistical analysts are unaware of the nature of control or intervention of groups A and B.Medications can only be identified by the serial number on the container. The serials are with the main researcher and will remain confidential until the end of the study. 2-3 candida colonization. Intervention 1: The intervention group will receive 10 drops of nystatin 100,000 oral units 3 times a day along with 10 oral drops of Ramnoflor (Lactobacillus Ramnosus) in the mouth once a day (4 times in total). Intervention 2: The control group will receive 10 drops of placebo (distilled water) 4 times a day. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Farzad Mashreghi
Mohammad Kermanshahi Hospital, Helal Ahmar Crossroad
Kermanshah Iran (Islamic Republic of) 6713733135 +98 83 3721 8202 farzadmashreghi@gmail.com Kermanshah University of Medical Sciences scientific Dr. Maziar Vakili Amini
Mohammad Kermanshahi Hospital, Helal Ahmar Crossroad
Kermanshah Iran (Islamic Republic of) 6713733135 +98 83 3721 8205 mzvakilia@ac.ir .com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Birth weight 2500 grams and less Age of hospitalization time 72 hours and less 1 day 3 days Both Maternal use of oral and topical antifungals during the last month of pregnancy P37.5 Neonatal candidiasis Treatment - Drugs Treatment - Other The intervention group will receive 10 drops of nystatin 100,000 oral units 3 times a day along with 10 oral drops of Ramnoflor (Lactobacillus Ramnosus) in the mouth once a day (4 times in total). The control group will receive 10 drops of placebo (distilled water) 4 times a day. Duration of hospitalization. Timepoint: End of study (10 days after starting the study). Method of measurement: According to documents. Necrotizing enterocolitis. Timepoint: End of study (10 days after starting the study). Method of measurement: Based on the doctor's diagnosis. Kermanshah University of Medical Sciences Approved 2021-08-31 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)