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Effect of Bacillus clausii in the management of acute diarrhoea in children

Comparative study on clinical efficacy of Bacillus Clausii ( Bifilac Clausi ) in the management of acute diarrhoea in children as an add on therapy with standard therapy- A randomized control study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062669
Enrollment
90
Registered
2024-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: A084- Viral intestinal infection, unspecified

Interventions

Intervention1: Bifilac Clausi: Bacillus Clausii 2 billion CFU Intervention2: Bifilac Clausi + ORS + Zinc: Bacillus clausii 2 billion CFU for 5 days BD ORS Zinc sulphate 20 mg for 14 days Control Inter

Sponsors

Tablets India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged between 6 months to 5 years old with care of diarrhoea less than 3 days

Exclusion criteria

Exclusion criteria: Children with severe dehydration Presence of systemic infections Children with known immunocompromising morbidities Children with severe acute malnutrition, Children with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination

Design outcomes

Primary

MeasureTime frame
Frequency of loose stoolsTimepoint: 24 hours and 72 hours and 120 hours

Secondary

MeasureTime frame
Changes in stool consistencyTimepoint: 24 hours & 72 hours & 120 hours

Countries

India

Contacts

Public ContactDr Aruna

Government Kilpauk Medical College

drkkarthika439@gmail.com9655516516

Outcome results

None listed

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