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

Combined Military Hospital Multan

Status and phase

Not yet enrolling

Early Phase 1

Conditions

To Assess the Mean Time of Resolution of Diarrhea

Treatments

Drug: Prebiotic

Other: Duration

Drug: Smecta

Study type

Interventional

Funder types

Other

Identifiers

NCT06588036

CMHMultan

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

6 months to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

100 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

: 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.

Treatment:

Other: Duration

Drug: Prebiotic

Duration of diarrhea

Active Comparator group

Description:

This will showcase the duration of diarrhea that the pediatric population had before receiving treatment.

Treatment:

Drug: Smecta

Drug: Prebiotic