NCT06887374

Brief Summary

This study aimed to compare WHO treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 14, 2025

Last Update Submit

March 14, 2025

Conditions

Acute Watery Diarrhea

Outcome Measures

Primary Outcomes (2)

  • Stool frequency

    A frequency of defecation of \< 3 stools per day marked the effectiveness of the treatment.

    5 days

  • Consistency of stools

    The treatment was considered effective if the consistency of stools became semi-solid.

    5 days

Study Arms (2)

Probiotic group

EXPERIMENTAL

Patients received 2 billion spores of probiotic (Bacillus clausii) every 12 hours, contained in a small bottle along with standard treatment as per WHO guidelines.

Drug: Probiotic Bacillus Clausii

No probiotic group

NO INTERVENTION

Patients received only standard treatment as per WHO guidelines.

Interventions

Probiotic Bacillus ClausiiDRUG

Patients were given 2 billion spores of probiotic (Bacillus clausii) every12 hours, contained in a small bottle.

Probiotic group

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both genders
  • Aged 6 to 59 months
  • Suffering from acute watery diarrhea for ≤ 7 days

You may not qualify if:

  • Children with blood in stool
  • With prior antibiotics use
  • Children under study with duration of stay more than 5 days
  • clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished
  • Immunocompromised children
  • Hypersensitivity to probiotics
  • With prior probiotic administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

  • Talha Hassan

    Children Hospital, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR

  • Muhammad Zeeshan

    Children Hospital, Lahore, Pakistan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 20, 2025

Study Start

March 1, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

March 20, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations

PA(1)