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IRCT20210817052216N1 IRCT 2021-10-02 Tehran University of Medical Sciences effect of probiotic on inflammatory diarrhea evaluation and comparison of the effect of diet with or without probiotic on the breastfeed infants proctocolitis 2021-09-23 anticipated 30 Complete https://irct.ir/trial/58337 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research we will use simple randomization by random number table to assign patients to test and control groups. To avoid disparity between group sizes, we will use replacement randomization. If the disparity exceeded the preset criterion of 3, we will generate another randomization list using simple randomization until we achieve a balanced group size. Randomization would be concealed using sequentially numbered, sealed, opaque envelopes, Blinding description: The A bottle contain probiotic and the B bottle contains water. The bottles are completely similar and would be given to the clinician. He/she and also the statistic analyzer does not know the relation between the alphabet and the content of bottles. N/A Caws milk protein allergy. Intervention 1: Intervention group: probiotic droplet containing lactobacillus ramnosous. Every 5 droplet conatins 5*10*8 cells of lipofilized lactobacillus ramnosous that would be prescribed for 1 month. Intervention 2: Control group: 5 droplet of distilled water would be prescribed daily for 1 month. 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 more information
public Shivasadat Khalifehsoltani
No 7, East lal St., Hashtbehesht St., Fatemi St.
Tehran Iran (Islamic Republic of) 1414744978 +98 21 8839 0538 shiva.khalifeh.ped@gmail.com Tehran University of Medical Sciences scientific Shivasadat Khalifehsoltani
No 7, East lal St., Hashtbehesht St., Fatemi St.
Tehran Iran (Islamic Republic of) 1414744978 +98 21 8839 0538 shiva.khalifeh.ped@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) age newborn to 12 months cow milk protein allergy breast fed 5 days 12 months Both taking probiotic/prebiotic in last two months taking antibiotic in the last two weeks existing systemic infection in clinical examination positive stool culture fever disease hirschsprung coagulopathy systemic disease formula fed Z91.011 Allergy to milk products Treatment - Drugs Placebo Intervention group: probiotic droplet containing lactobacillus ramnosous. Every 5 droplet conatins 5*10*8 cells of lipofilized lactobacillus ramnosous that would be prescribed for 1 month. Control group: 5 droplet of distilled water would be prescribed daily for 1 month. Elimination of clinical symptoms of allergy; negative white blood cells in stool. Timepoint: Evaluation of stool WBC in the start and after 4 weeks. Method of measurement: Stool Exam. Tehran University of Medical Science Approved 2020-07-27 Ethics committee of Tehran University of Medical Science No. 7, Gharib Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)