Acute Hepatitis A in children. Hepatitis A without hepatic coma
Conditions
Interventions
Intervention 1: Intervention group (probiotic): The intervention group will receive a commercial probiotic capsule named ProKid (manufactured by PharmaMed). Each capsule contains the strain Lactobacil
Sponsors
Zahedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Months to 18 Years
Inclusion criteria
Inclusion criteria: ge Range: Children aged 2 months to 18 years. Disease Diagnosis: Confirmation of acute hepatitis A virus infection by a positive serological test for IgM anti-HAV. Evidence of Hepatocellular Injury: Elevated serum alanine aminotransferase (ALT) level = 2 times the upper limit of normal at the time of admission and study entry. Ability to Receive Intervention: Capacity to orally ingest medications or supplements. Informed Consent: Provision of written informed consent by a parent or legal guardian. Informed assent obtained from children capable of understanding, typically those over 7 years of age.
Exclusion criteria
Exclusion criteria: Chronic Liver Disease: Presence of chronic liver conditions such as Wilson's disease, autoimmune hepatitis, or biliary atresia. Viral Co-infection: Concurrent active infection with other hepatitis viruses (B, C, E) or HIV. Acute Liver Failure: Diagnosis of acute liver failure, defined as an INR > 1.5 accompanied by hepatic encephalopathy of any degree. Known Immunodeficiency: Presence of any known primary or acquired immunodeficiency, or current use of immunosuppressive medications. Active Systemic Infection: Presence of an active systemic bacterial infection or sepsis at the time of study entry. History of Gastrointestinal Surgery: A history of gastrointestinal surgery that would affect nutrient absorption. History of Hypersensitivity: A known hypersensitivity or allergic reaction to dairy products or any component of the probiotic/placebo formulation used in the study. Requirement for Intensive Care: Patients requiring intensive care unit (ICU) admission at the time of enrollment. Recent Use of Probiotics or Antibiotics: Consumption of probiotic supplements or oral/intravenous antibiotics within the two weeks prior to hospitalization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Alanine Aminotransferase (ALT) Level: The plasma concentration of the ALT enzyme, measured using the standard enzymatic method on an automated autoanalyzer (in units per liter - U/L), at baseline (day 0), days 2, 4, 7, 14, and at the time of hospital discharge. Timepoint: Baseline (pre-intervention) - Day 0, During treatment: Days 2, 4, and 7 post-intervention, At the time of hospital discharge, Follow-up visit: Day 14 post-intervention. Method of measurement: Measurement is performed using the standard enzymatic method (IFCC) on an automated biochemistry autoanalyzer with a standard commercial kit. The sample used is serum separated from venous blood, and the result is reported in units per liter (U/L).;Serum Aspartate Aminotransferase (AST) Level: The plasma concentration of the AST enzyme, measured using the standard enzymatic method on an automated autoanalyzer (in units per liter - U/L), at baseline (day 0), days 2, 4, 7, 14, and at the time of hospital discharge. Timepoint: Baseline (pre-intervention) - Day 0, During treatment: Days 2, 4, and 7 post-intervention, At the time of hospital discharge, Follow-up visit: Day 14 post-intervention. Method of measurement: Measurement is performed using the standard enzymatic method (IFCC) on an automated biochemistry autoanalyzer with a standard commercial kit. The sample used is serum separated from venous blood, and the result is reported in units per liter (U/L).;Serum Albumin Level: The plasma concentration of albumin protein, measured using the standard method on an automated autoanalyzer (in grams per deciliter - g/dL), at baseline (day 0), days 2, 4, 7, 14, and at the time of hospital discharge. Timepoint: Baseline (pre-intervention) - Day 0, During treatment: Days 2, 4, and 7 post-intervention, At the time of hospital discharge, Follow-up visit: Day 14 post-intervention. Method of measurement: Measurement is performed using the bromocresol green colorimetric method on an automate | — |
Secondary
| Measure | Time frame |
|---|---|
| The total number of days the patient is hospitalized, from the moment of formal admission to the ward until the moment of medical discharge. Timepoint: The measurement time point is the day of the patient's discharge from the hospital. Method of measurement: Calculation using the date and time recorded in the Hospital Information System (HIS) for admission and discharge. The difference between the discharge date and admission date is calculated and reported as a full number of days.;The incidence and type of potential adverse events related to the intervention, which are actively monitored during the study period. These events include: new or worsened diarrhea, vomiting, abdominal distension, new systemic infection symptoms (e.g., fever of unknown origin), and new-onset skin rash. Timepoint: Adverse events are monitored daily during the hospitalization period and also at the follow-up visit on day 14. Method of measurement: Data collection through: 1) Daily direct inquiry of parents/guardians regarding the child's condition, 2) Daily physical examination by research personnel, and 3) Review of the patient's medical records. Any reported event is recorded in a Case Report Form (CRF) and graded using criteria for discomfort, interference with daily activity, and need for intervention.;The duration (in days) from hospital admission until the serum Alanine Aminotransferase (ALT) level returns to the normal range (below 40 units per liter). Timepoint: This outcome is measured and recorded daily from admission until the endpoint condition (ALT < 40 U/L) is met. Method of measurement: Using daily measurements of serum ALT levels (method as described for the primary outcome) and recording the date when the value first falls below the threshold of 40 U/L. The time interval between the admission date and this recorded date is calculated.;The duration (in days) from admission until the complete resolution of a set of key clinical symptoms, including: 1) resolution of fever (te | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactManijeh Khalili
Zahedan University of Medical Sciences
Outcome results
None listed