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IRCT20201011048995N1 IRCT 2021-02-18 Ahvaz University of Medical Sciences The effect of Lactose-Free vs Lactose-Containing Formula in Dietary Management of Acute Diarrhea in infants 3-24 month Comparison of Lactose-Free vs Lactose-Containing Formula in Dietary Management of Acute Diarrhea in infants 3-24 months admitted in Golestan and Abuzar hospitals in Ahvaz 2015-05-15 anticipated 100 Complete https://irct.ir/trial/51761 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A participant list was made consisting of the patients’ ID that were numbered based on the order of referral. After completion of the eligible participants list, included patients are randomly assigned to two groups of at least 52 members using a computer-generated random queue with blocks size of 4 and an allocation ratio of 1:1 (permuted block randomization method). In other words, each block of participants could be arranged in 6 different ways, including AABB, ABAB, ABBA, BAAB, BABA, BBAA (A: group 1, B: group 2) for the purpose of achieving the allocation ratio of 1:1. Using random number generator application, then, one of the possible arrangements is randomly assigned to each block. AABB, ABAB, ABBA, BAAB, BABA, BBAA 1 2 3 4 5 6 7 8 9 10 11 12 …. Participants number:. 3 Diarrhea in infants. Intervention 1: Intervention group: All patients undergo standard treatment for diarrhea (intravenous and oral fluid therapy and zinc sulfate syrup) and depending on the usual consumption of infants, we will first give the lactose-free quota to mothers of infants in the intervention group. And while teaching them how to prepare it properly, we ask them to use lactose-free milk powder for a week. Intervention 2: Control group: All patients undergo standard treatment for diarrhea (intravenous and oral fluid therapy and zinc sulfate syrup) and mothers of infants in the control group are also explained the correct way to prepare powdered milk (normal, lactose). 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 After consulting with respected professors, the publication plan will be decided. Best Regards
public Shideh Assar
No. 52, 5th Floor, Berlian Complex, 11 East St, Kian Pars, Ahvaz, Khouzestan
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3374 3019 assarsh@yahoo.com Ahvaz University of Medical Sciences scientific Shideh Assar
No. 52, 5th Floor, Berlian Complex, 11 East St, Kian Pars.
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3374 3019 assarsh@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Infants 3 to 24 months Feeding with formula Acute diarrhea (less than 14 days) 3 months 24 months Both Diarrhea more than a week from the start of treatment Infants with congenital disease Having an underlying systemic disease Severe malnutrition Having severe vomiting History of antibiotic use in the last two weeks Having bloody stools History of therapeutic milk powder consumption P78.3 Noninfective neonatal diarrhea Diagnosis Diagnosis Intervention group: All patients undergo standard treatment for diarrhea (intravenous and oral fluid therapy and zinc sulfate syrup) and depending on the usual consumption of infants, we will first give the lactose-free quota to mothers of infants in the intervention group. And while teaching them how to prepare it properly, we ask them to use lactose-free milk powder for a week. Control group: All patients undergo standard treatment for diarrhea (intravenous and oral fluid therapy and zinc sulfate syrup) and mothers of infants in the control group are also explained the correct way to prepare powdered milk (normal, lactose). Number of times diarrhea. Timepoint: Daily for the first three days and after a week. Method of measurement: Note the number of watery stools per day In the data collection form. Weight. Timepoint: at the time of referral and after two, three and seven days from the start of hospitalization. Method of measurement: Scale. Weight. Timepoint: After 48 and 72 hours and a week later. Method of measurement: Scale. Number of times diarrhea. Timepoint: During the first three days and after a week. Method of measurement: questionnaire. Ahvaz University of Medical Sciences Approved 2015-09-19 Ethics Committee of Ahwaz University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences and Health Services, Golestan Highway, Ahvaz, Khuzestan Province. Ahvaz Khouzestan Iran (Islamic Republic of)