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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
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06588036
Enrollment
100
Registered
2024-09-19
Start date
2024-09-15
Completion date
2024-12-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Assess the Mean Time of Resolution of Diarrhea

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.

Interventions

DRUGPrebiotic

. 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.

every participant is alloted a group based on RCT.

DRUGSmecta

Group 4 will be given smecta scahet

Sponsors

Saglik Bilimleri Universitesi
CollaboratorOTHER
Combined Military Hospital Multan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
resolution of diarrhea3 monthsmean time of resolution of diarrhea in different intervention groups

Contacts

Primary ContactAmir A Awan, mbbs
amiraslam86@hotmail.com+923248590127
Backup ContactLaraib F Gardezi, mbbs
laraibfatimagardezi@gmail.com+923477470170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026