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IRCT20260723070318N1 IRCT 2026-08-24 Oroumia University of Medical Sciences Effect of Probiotic Supplementation in Children with Acute Gastroenteritis Effect of Probiotic Supplementation on Hospital Length of Stay and Clinical Outcomes in Children with Acute Gastroenteritis: A Randomized Double-Blind Placebo-Controlled Trial 2026-09-23 anticipated 40 Pending https://irct.ir/trial/92659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a randomized, double-blind, placebo-controlled parallel clinical trial. Eligible children will be randomly assigned in a 1:1 ratio to receive either probiotic supplementation or placebo in addition to standard treatment for acute gastroenteritis. The primary outcome is hospital stay duration. Secondary outcomes include diarrhea frequency, vomiting frequency, fever, abdominal pain, and dehydration severity, Randomization description: Eligible participants will be randomly allocated to the intervention and control groups in a 1:1 ratio using block randomization with a fixed block size of 4. The random allocation sequence will be generated by Random Allocation Software. Individual participants will be considered as the randomization unit. The generated allocation sequence will be concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent person who is not involved in participant recruitment or outcome assessment. The envelopes will be opened only after participant enrollment, confirmation of eligibility criteria, and completion of baseline assessment to ensure allocation concealment, Blinding description: Participants, their parents or legal guardians, healthcare providers responsible for patient care, outcome assessors, and the statistician will be blinded to the assigned intervention. The probiotic and placebo will be identical in appearance, color, packaging, and administration method. Only the person responsible for preparing and dispensing the intervention will have access to the randomization codes. The allocation codes will remain confidential until completion of data collection and statistical analysis. N/A Acute Gastroenteritis. Intervention 1: Intervention group: Children with acute gastroenteritis will receive probiotic supplementation in addition to standard treatment. The probiotic supplement will be administered according to the study protocol during the hospitalization period. Intervention 2: Control group: Children with acute gastroenteritis will receive placebo in addition to standard treatment. The placebo will be identical to the probiotic supplement in appearance and administration method. Yes - There is a plan to make this available What will be shared: Study protocol, statistical analysis plan, informed consent form, clinical study report, individual participant data (IPD), and supporting study documentation. The shared materials will include the final study protocol, statistical analysis plan, anonymized individual participant-level data, final clinical study report, and related methodological documents generated during the clinical trial. When: Access to the study documents and data will become available after publication of the primary results of the trial. The materials will be available beginning 6 months after publication of the main study findings and will remain accessible for at least 5 years. To whom: Qualified researchers, including researchers affiliated with academic institutions, research organizations, and other scientific institutions, may request access to the available study materials. Requests will be evaluated based on scientific relevance and compliance with ethical requirements. Conditions: The shared data and documents may be used for scientifically valid research purposes, including secondary analyses, validation of published findings, and evidence synthesis. Users must ensure appropriate ethical approval when required, maintain data confidentiality, and agree not to attempt participant re-identification. Where to obtain: Requests for access should be submitted to the corresponding author or principal investigator of the study through the official institutional email address. How to obtain: Requests will be reviewed by the study investigators. The review process will include assessment of the scientific purpose, feasibility of the proposed analysis, ethical considerations, and compliance with data protection requirements. Approved requests will receive access after completion of the required administrative procedures and signing of a data use agreement when applicable. Comments: All shared datasets will be de-identified before release. Access to individual participant data will comply with ethical principles, participant confidentiality requirements, and applicable regulations.
public Sarvin Pashapour
Shahid Motahari Hospital, Urmia University of Medical Sciences, Urmia, West Azerbaijan, Iran
Urmia Iran (Islamic Republic of) 5714615463 +98 44 3275 0001 Sarvin.pashapour@gmail.com Oroumia University of Medical Sciences scientific Sarvin Pashapour
Shahid Motahari Hospital, Urmia University of Medical Sciences, Urmia, West Azerbaijan, Iran
Urmia Iran (Islamic Republic of) 5714615463 +98 44 3275 0001 Sarvin.pashapour@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Children aged 6 months to 5 years with acute gastroenteritis requiring hospitalization, diagnosed based on clinical symptoms including acute diarrhea with or without vomiting, and moderate to severe dehydration. Written informed consent from parents or legal guardians is required. 6 months 5 years Both Children with chronic renal, hepatic, metabolic or gastrointestinal diseases, known immunodeficiency, previous probiotic use within the last 6 months, concurrent participation in another clinical trial, and lack of parental consent. A09 Infectious gastroenteritis and colitis, unspecified Treatment - Drugs Placebo Intervention group: Children with acute gastroenteritis will receive probiotic supplementation in addition to standard treatment. The probiotic supplement will be administered according to the study protocol during the hospitalization period. Control group: Children with acute gastroenteritis will receive placebo in addition to standard treatment. The placebo will be identical to the probiotic supplement in appearance and administration method. Length of hospital stay. Timepoint: From hospital admission to discharge. Method of measurement: Recording the duration of hospitalization based on medical records and calculating the number of hospitalization days. Frequency of diarrhea episodes. Timepoint: Daily from study enrollment until hospital discharge. Method of measurement: Recording the number of watery or loose stool episodes per 24 hours based on reports from parents or legal guardians and medical records. Frequency of vomiting episodes. Timepoint: Daily from study enrollment until hospital discharge. Method of measurement: Recording the number of vomiting episodes per 24 hours based on reports from parents or legal guardians and medical records. Presence of fever. Timepoint: Daily from study enrollment until hospital discharge. Method of measurement: Measurement of body temperature using a standard medical thermometer and recording the presence or absence of fever in medical records. Abdominal pain. Timepoint: Daily from study enrollment until hospital discharge. Method of measurement: Assessment of the presence or absence of abdominal pain based on clinical examination by the physician and reports from parents or legal guardians. Severity of dehydration. Timepoint: At study enrollment and daily until hospital discharge. Method of measurement: Assessment of dehydration severity based on clinical signs including mental status, thirst, oral mucosal condition, capillary refill, pulse, and vital signs by the treating physician. Oroumia University of Medical Sciences Approved 2026-07-01 Ethics Committee of Urmia University of Medical Sciences Research and Technology Deputy, Urmia University of Medical Sciences, Orzhans Alley, Resalat Street, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)