NCT06588036

A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies in the Paediatric Population

A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Combined Military Hospital Multan · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

The objective of this research is to assess the mean time of resolution of diarrhea in pediatric patients receiving different intervention combinations for the management of acute diarrhea. Specifically, the study aims to compare the effectiveness of four intervention groups: 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. 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.

Detailed description

This study will employ a randomized controlled trial (RCT) design and will be conducted at the Combined Military Hospital (CMH) in Multan, Pakistan, from September 15, 2024, to December 15, 2024. A total of 100 patients will be included, with approximately 25 patients allocated to each intervention group. The sampling technique will be convenience sampling, where patients meeting the inclusion criteria and presenting during the study period will be recruited. 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

• To Assess the Mean Time of Resolution of Diarrhea

Interventions

Type	Name	Description
DRUG	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.
OTHER	Duration	every participant is alloted a group based on RCT.
DRUG	Smecta	Group 4 will be given smecta scahet

Timeline

• Start date: 2024-09-15
• Primary completion: 2024-12-15
• Completion: 2024-12-30
• First posted: 2024-09-19
• Last updated: 2024-09-19