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NCT Number: NCT06588036

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

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.

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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prebiotic

Drug

. 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 names: zinc, adsorbent, anti-secretory

Duration

Other

every participant is alloted a group based on RCT.

Smecta

Drug

Group 4 will be given smecta scahet

Primary outcomes

  1. resolution of diarrhea

    Time frame: 3 months

    mean time of resolution of diarrhea in different intervention groups

Study contacts

Contact information is provided by the study sponsor or research team.

Amir A Awan, mbbs

CONTACT

[email protected]

+923248590127

Laraib F Gardezi, mbbs

CONTACT

[email protected]

+923477470170

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Multan

Other

Collaborators

  • Saglik Bilimleri Universitesi

Registry information

Official study title

A Comprehensive Analysis of the Comparative Efficacy of Multimodal Diarrhea Therapies

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.