Clinical trial NCT06588036: A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies in the Paediatric Population
Official title: A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: To Assess the Mean Time of Resolution of Diarrhea
Lead sponsor: Combined Military Hospital Multan
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion 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 chronic diarrhea or underlying gastrointestinal disorders.
* 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.

Primary outcomes:
measure: resolution of diarrhea
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CMH Multan
name: Muhammad F Shafiq
role: STUDY_CHAIR
References: