Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588036
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies in the Paediatric Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 280 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 005 will be considered statistically significant
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 280 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 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None