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Efficacy of Bacillus Clausii in Acute Diarrhoea in Children

An Open Labelled Study on Clinical Efficacy of Bacillus Clausii in Management of Acute Diarrhoea in Children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/033918
Enrollment
50
Registered
2021-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Bacillus Clausii 2 billion CFU: Bacillus clausii 2 billion probiotic for kids â?? Maintains the right kind of gut flora balance Restores internal bacterial balance to help improve immu

Sponsors

Tablets India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged between 6 months and 10 years with acute bacterial gastroenteritis or acute viral gastroenteritis. Acute diarrhea for a duration of

Exclusion criteria

Exclusion criteria: Severe dehydration and electrolyte imbalance Presence of systemic infections Children with known immunocomprising morbidities Children with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination.

Design outcomes

Primary

MeasureTime frame
1.No. of stools per day after 24 hours of treatment 2.No. of stools per day after 48 hours of treatment 3.Duration of diarrhoea in days Timepoint: 1.No. of stools per day after 24 hours of treatment 2.No. of stools per day after 48 hours of treatment 3.Duration of diarrhoea in days

Secondary

MeasureTime frame
1.No. of episodes of vomiting 2.Changes in Stool consistency from 24 hrs to 48 hrs. 3.Body weight at baseline and day 5. Timepoint: 24 hrs to 48 hrs and Day 5

Countries

India

Contacts

Public ContactRamanath A

Panimalar Medical College Hospital and Research Institute,

chandra.ramanath82@gmail.com9884750160

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026