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

NCT06588036 | Not Yet Recruiting Early Phase 1

• 1 other identifier: CMHMultan
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

To Assess the Mean Time of Resolution of Diarrhea

Outcome Measures

Primary Outcomes (1)

• resolution of diarrhea

  mean time of resolution of diarrhea in different intervention groups

  3 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

: 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.

Drug: Prebiotic; Other: Duration

Duration of diarrhea

ACTIVE COMPARATOR

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

Drug: Prebiotic; Drug: Smecta

Interventions

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.

Also known as: zinc, adsorbent, anti-secretory

Duration of diarrhea; Intervention Group

Duration OTHER

every participant is alloted a group based on RCT.

Intervention Group

Smecta DRUG

Group 4 will be given smecta scahet

Duration of diarrhea

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Combined Military Hospital Multan: lead
• Saglik Bilimleri Universitesi: collaborator

MeSH Terms

Interventions

Prebiotics; Zinc; Time; smecta

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Physical Phenomena

Study Officials

• Muhammad F Shafiq

  CMH Multan

  STUDY CHAIR

Central Study Contacts

Amir A Awan, mbbs

CONTACT

+923248590127; amiraslam86@hotmail.com

Laraib F Gardezi, mbbs

CONTACT

+923477470170; laraibfatimagardezi@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share