Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorChildren Hospital and Institute of Child Health, Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enterogermina

    Drug

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

  • Ecotec

    Drug

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

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Bacillus clausii GroupActive comparator 1 intervention
Group B: Multistrain Probiotic GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Up to 5 days after initiation of treatment

Secondary outcomes

1

Daily Stool Frequency

Number of stools passed per day during the treatment period.

Time frame
Daily for 5 days after initiation of treatment
2

Stool Consistency

Change in stool consistency assessed daily during the treatment period.

Time frame
Daily for 5 days after initiation of treatment

Other outcomes

Sponsors and contacts

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