NCT07660367

Brief Summary

This randomized controlled trial will compare Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) in children aged 1-5 years with acute watery diarrhea. Participants will receive one of the probiotic treatments along with standard therapy including oral rehydration solution and zinc supplementation. The study will evaluate the duration of diarrhea, stool frequency, and stool consistency.

Trial Health

63
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Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress2%
Aug 2026Nov 2026

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 16, 2026

Last Update Submit

June 20, 2026

Conditions

Acute Watery Diarrhea

Keywords

Bacillus clausiiMultistrain probioticsAcute watery diarrheaChildrenRandomised controlled trialZinc supplementationOral rehydration solution

Outcome Measures

Primary Outcomes (1)

  • Duration of Diarrhea

    The duration of acute diarrhea is determined by the timeframe (measured in days) spanning from the initial occurrence of abnormal (loose or liquid) stools to the subsequent return of normal stool consistency. This assessment will consider both the frequency of daily stools and their consistency.

    Up to 5 days after initiation of treatment

Secondary Outcomes (2)

  • Daily Stool Frequency

    Daily for 5 days after initiation of treatment

  • Stool Consistency

    Daily for 5 days after initiation of treatment

Study Arms (2)

Bacillus clausii Group

ACTIVE COMPARATOR

Participants will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation.

Drug: Enterogermina

Multistrain Probiotic Group

ACTIVE COMPARATOR

Participants will receive a multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation.

Drug: Ecotec

Interventions

EnterogerminaDRUG

Bacillus clausii oral suspension containing 2 billion spores administered once daily for 5 days.

Bacillus clausii Group
EcotecDRUG

Multistrain probiotic preparation containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus administered once daily for 5 days.

Multistrain Probiotic Group

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patient with Acute watery diarrhea aged 1 year to 5 years.
  • Both genders will be included.
  • Patients whose guardians/ parents will give informed consent will participate in the study.
  • Patients having mild to moderate dehydration will be included in study.
  • Patients having mild to moderate malnutrition will be included in study.

You may not qualify if:

  • Children having history of chronic diarrhea.
  • Children having history of blood in stools.
  • Children having cholera.
  • Children with evidence of concurrent systemic infections other than acute diarrhea (e.g. respiratory tract infections, urinary tract infections, measles, meningitis etc).
  • Children with known immunodeficiency disorders or undergoing immunosuppressive treatments (e.g., chemotherapy, corticosteroids).
  • Children who have received antibiotics or zinc within the past 72 hours prior to enrollment, as this may interfere with gut flora and probiotic efficacy.
  • Children who have received probiotics as a treatment for the current episode of diarrhea prior to study enrollment.
  • Children with known allergies or hypersensitivity to probiotic components used in the study.
  • Children who needed I/V antibiotics or I/V rehydration after enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital and Institute of Child Health, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Mamoona feroz

CONTACT

+923315616443mamoona.feroz@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)