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IRCT2016061128386N1 IRCT 2016-07-04 Vice chancellor for research, Alborz University of Medical Sciences Evaluation of the effects of synbiotic supplementation on weight gain, fecal ph, acetate, lactate, calprotectin in preterm infants - Evaluation of the effects of synbiotic supplementation on weight gain, fecal ph, acetate, lactate, calprotectin in preterm infants 2016-06-21 anticipated 160 Complete https://irct.ir/trial/23044 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Table of random numbers. N/A Preterm infants. Intervention 1: Intervention group 1: this group will received 5 drops of milk fortified with 108 Colony Forming Unit per ml (cfu/ml) of Lactobacillus plantarum and 0.8 grams per dL fructooligosaccharides twice a day for two weeks. Intervention 2: Intervention 2: this group will received 5 drops of milk fortified with 108 cfu/ml of Lactobacillus plantarum twice a day for two weeks. Intervention 3: Intervention 3: this group will received 5 drops of milk fortified with 0.8 grams per dL fructooligosaccharides twice a day for two weeks. Intervention 4: Control group: this group will received regular milk twice a day for 2 weeks.
public Mahboobeh Mehrabani Natanzi
Faculty of Medicine, Eshteraki Blvd. Baghestan, Karaj
Karaj Iran (Islamic Republic of) +98 26 3458 4919 mahboobehmehrabani@yahoo.com Alborz University of Medical Sciences scientific Zohreh Khodaii
Faculty of Medicine, Eshteraki Blvd. Baghestan, Karaj
Karaj Iran (Islamic Republic of) 00982634584919 +98 26 3458 4919 zkhidaii@yahoo.com Alborz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Infants weighing less than 2500 g or 37 week; all premature infants hospitalized in Kamali Hospital of Karaj Exclusion criteria: in the case of clinical symptoms of Sepsis (including severe lethargy, inability to feed, frequent vomiting, impaired consciousness, seizures, severe abdominal distention, laboratory findings such as positive blood culture and elevated CRP); critically ill patient for any reason. no limit 14 days Both P78.9 Digestive system disorders of fetus and newborn Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: this group will received 5 drops of milk fortified with 108 Colony Forming Unit per ml (cfu/ml) of Lactobacillus plantarum and 0.8 grams per dL fructooligosaccharides twice a day for two weeks Intervention 2: this group will received 5 drops of milk fortified with 108 cfu/ml of Lactobacillus plantarum twice a day for two weeks Intervention 3: this group will received 5 drops of milk fortified with 0.8 grams per dL fructooligosaccharides twice a day for two weeks Control group: this group will received regular milk twice a day for 2 weeks. Body Weight. Timepoint: 14 days. Method of measurement: weightening for body weight. Fecal lactate. Timepoint: 14 days. Method of measurement: GC-MASS. Fecal calprotectin. Timepoint: 14 days. Method of measurement: ELISA kit. Fecal acetate. Timepoint: 14 days. Method of measurement: GC-MASS. Duration of hospitalization in. Timepoint: day of discharge from hospital. Method of measurement: Counting days. Vice chancellor for research, Alborz University of Medical Sciences Approved 2016-05-02 Alborz University of Medical Sciences Faculty of medicine, Golestan 1, Eshteraki, Baghestan, Karaj Karaj Iran (Islamic Republic of)