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IRCT20241029063537N1 IRCT 2025-01-14 Semnan University of Medical Sciences Investigating the effect of probiotics in gastroenteritis Investigating the effect of Kidi Lact probiotic supplement administration on the symptoms of diarrhea and dehydration caused by gastroenteritis in children 2025-03-21 anticipated 400 Complete https://irct.ir/trial/80778 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the block randomization method, considering blocks of 4, among the 6 possible states for blocks of four including two people from the intervention group (A) and two people from the control group (B): (1.AABB, 2.ABAB, 3.BBAA, 4.BABA, 5.ABBA, 6.BAAB), Using the RANDBETWEEN(1,6) command in Excel software, the number of blocks corresponding to the sample size will be randomly selected, and a random allocation sequence will be created. The participants are equally divided into intervention and control groups based on the established allocation sequence. The randomization sequence will be placed in sealed, opaque envelopes to ensure allocation concealment. These envelopes are numbered in sequence and will be opened by the person responsible for allocation only after the participant has accepted the study, Blinding description: Patients, researchers, data collectors and data analysts are unaware of the study conditions. The placebo and the drug will be the same in terms of appearance, taste and method of administration. 3 Gastroenteritis. Intervention 1: Intervention group: Kidi Lact Sachet is an unflavored edible sachet containing safe and beneficial bacterial strains and prebiotic fructooligosaccharide (FOS). The company that manufactures the drug is Zist Takhmir. The case group will be children with gastroenteritis, who will receive Kidi Lact probiotic supplement for 10 days and one sachet per day. Intervention 2: Control group: Children with gastroenteritis will receive a placebo. The placebo will be prepared by the Zist Takhmir drug manufacturer, and the way to use it is the same as how to use the medicine. 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 Houman Parsaie
Semnan - Golestan town - above Al-Ghadir Square - Kausar Hospital
Semnan Iran (Islamic Republic of) 3519899558 +98 23 3365 4162 houman70parsaie@semums.ac.ir Semnan University of Medical Sciences scientific Houman Parsaie
Semnan - Golestan town - above Al-Ghadir Square - Kausar Hospital
Semnan Iran (Islamic Republic of) 3519899558 +98 23 3365 4162 houman70parsaie@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Consent to participate in a research project Suffering from acute gastroenteritis and signs and symptoms of acute non-bloody diarrhea, and mild to moderate dehydration that have an indication for liquid therapy Refer to the medical center within the first 72 hours from the onset of symptoms. 12 months 72 months Both Unwillingness to participate in a research project Gastroenteritis patients who are more than 6 years old and less than one year old Children who have been sick for more than 72 hours Children with chronic gastrointestinal disease (such as inflammatory bowel disease and Celiac disease), severe malnutrition (grade 2 and 3), pancreatic insufficiency Children with underlying diseases such as allergy to probiotic products Children with kidney failure, chronic lung diseases, congenital heart failure and clear neurological disease Children who receive antibiotics or acid-blocking drugs or who have taken probiotics for any reason within a week before entering the study. Change in treatment due to new diagnosis, treatment in the form of receiving serum in medical centers before going to Amir--al-Momenin Hospital The existence of unexplained abnormal findings in the urine sample A08 Viral and other specified intestinal infections Treatment - Drugs Placebo Intervention group: Kidi Lact Sachet is an unflavored edible sachet containing safe and beneficial bacterial strains and prebiotic fructooligosaccharide (FOS). The company that manufactures the drug is Zist Takhmir. The case group will be children with gastroenteritis, who will receive Kidi Lact probiotic supplement for 10 days and one sachet per day. Control group: Children with gastroenteritis will receive a placebo. The placebo will be prepared by the Zist Takhmir drug manufacturer, and the way to use it is the same as how to use the medicine. Severity of dehydration. Timepoint: The beginning and end of the study. Method of measurement: Urine test (BUN, Creatinine,and urine specific gravity); blood test (sodium and potassium); clinical symptoms (nurse's report and child's mother's report). Frequency of diarrhea. Timepoint: The beginning and end of the study. Method of measurement: The report of the nurse and the report of the child's mother. Semnan University of Medical Sciences Approved 2024-07-08 Research Ethics Committee of Semnan University of Medical Sciences Semnan - Golestan town - above Al-Ghadir Square - Kausar Hospital Semnan Semnan Iran (Islamic Republic of)