A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies in the Paediatric Population
NCT ID: NCT06588036
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
100 participants
INTERVENTIONAL
2024-09-15
2024-12-30
Brief Summary
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Detailed Description
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The main study variables include the intervention groups-Group 1: zinc and probiotic, Group 2: zinc, probiotic, and prebiotics, Group 3: zinc, probiotics, and anti-secretory, and Group 4: zinc, probiotic, anti-secretory, and adsorbent-time to resolution of diarrhea, and clinical outcomes. Data will be collected through caregiver interviews, clinical examinations, and a review of medical records. A structured questionnaire or proforma will be used to gather relevant information from patients and caregivers regarding demographic characteristics, clinical presentation, interventions received, and outcomes.
\*\*Data Analysis Procedure:\*\* Statistical analysis will be conducted using SPSS software, version 28.0 (IBM Corp., Armonk, NY). Both quantitative and qualitative data will be analyzed, with descriptive statistics such as mean, median, standard deviation, and frequency distributions used to summarize the demographic and clinical characteristics of the study population. For comparing outcomes between intervention groups, inferential statistical tests such as ANOVA for continuous variables and the Chi-square test for categorical variables will be employed, depending on the nature of the data. Confounding variables will be controlled through multivariate analysis, and a p-value of less than 0.05 will be considered statistically significant.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Intervention Group
: Group 1 receiving zinc and probiotic supplementation, Group 2 receiving zinc, probiotic, and prebiotics. Group 3 receiving zinc, probiotics, and anti-secretory agents, and Group 4 receiving zinc, probiotic, anti-secretory agents, and adsorbents.
Prebiotic
. The primary outcome measure will be the mean time from the initiation of treatment to the resolution of diarrhea symptoms. This objective seeks to provide evidence-based insights into the optimal management strategies for childhood diarrhea and inform clinical practice guidelines.
Duration
every participant is alloted a group based on RCT.
Duration of diarrhea
This will showcase the duration of diarrhea that the pediatric population had before receiving treatment.
Prebiotic
. The primary outcome measure will be the mean time from the initiation of treatment to the resolution of diarrhea symptoms. This objective seeks to provide evidence-based insights into the optimal management strategies for childhood diarrhea and inform clinical practice guidelines.
Smecta
Group 4 will be given smecta scahet
Interventions
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Prebiotic
. The primary outcome measure will be the mean time from the initiation of treatment to the resolution of diarrhea symptoms. This objective seeks to provide evidence-based insights into the optimal management strategies for childhood diarrhea and inform clinical practice guidelines.
Duration
every participant is alloted a group based on RCT.
Smecta
Group 4 will be given smecta scahet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pediatric patients, both male and female, aged 6 months to 5 years presenting with acute diarrhea at CMH Multan.
* Patients or caregivers willing to provide informed consent for participation in the study.
Exclusion Criteria
* Pediatric Patients with severe dehydration requiring immediate medical intervention.
* Pediatric Patients with a history of allergy or intolerance to any of the study interventions.
* Pediatric Patients with severe comorbidities or immunocompromised status.
6 Months
5 Years
ALL
No
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Combined Military Hospital Multan
OTHER
Responsible Party
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Aamir Aslam Awan
Assistant Professor
Principal Investigators
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Muhammad F Shafiq
Role: STUDY_CHAIR
CMH Multan
Central Contacts
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Other Identifiers
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CMHMultan
Identifier Type: -
Identifier Source: org_study_id
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