Effect of Probiotic Supplementation on Hospital Length of Stay and Clinical Outcomes in Children with Acute Gastroenteritis: A Randomized Double-Blind Placebo-Controlled Trial

To evaluate the effect of probiotic supplementation on hospital stay duration and clinical outcomes in hospitalized children with acute gastroenteritis

A randomized, double-blind, parallel-group, placebo-controlled clinical trial with a 1:1 allocation ratio. Participants will be allocated using block randomization with a fixed block size of 4. The randomization unit is the individual participant, and allocation concealment will be performed using sequentially numbered, opaque, sealed envelopes.

The study will be conducted at, Motahari Hospital, UMSU. Eligible children with acute gastroenteritis will be enrolled after eligibility assessment and written informed consent from parents or legal guardians. Participants will be randomly assigned to probiotic or placebo groups in a 1:1 ratio, with both groups receiving standard treatment. Participants, parents or legal guardians, healthcare providers, outcome assessors, and the statistician will be blinded to group allocation.

Children aged 6 months to 5 years with acute gastroenteritis requiring hospitalization, acute diarrhea with or without vomiting, and moderate to severe dehydration; chronic renal, hepatic, metabolic, or gastrointestinal diseases, known immunodeficiency, probiotic use within the last 6 months, concurrent participation in another clinical trial, and lack of parental consent were considered exclusion criteria

The intervention group will receive probiotic supplementation in addition to standard treatment for acute gastroenteritis. The control group will receive placebo in addition to standard treatment. The probiotic and placebo will be identical in appearance, color, packaging, and administration method.

Hospital stay duration; diarrhea frequency; vomiting frequency; fever; abdominal pain; dehydration severity

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.

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.

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.

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.

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.

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.

Requests for access should be submitted to the corresponding author or principal investigator of the study through the official institutional email address.

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.

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.