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A clinical trial to study the effects of probiotic formulation with zinc enriched yeast in children with diarrhoea.

A phase III, open label, non-randomised study to assess safety and efficacy of probiotic formulation with zinc enriched yeast in children with acute diarrhoea.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000009
Enrollment
Unknown
Registered
2009-04-16
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

None listed

Interventions

Intervention1: Lactobacillus Rhamnosus + Saccharomyces Boulardi + Zinc enriched yeast: Once daily Control Intervention1: Nil: nil

Sponsors

Aristo Pharmaceuticals Pvt. Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children of age 6-60 months with acute diarrhoea.

Exclusion criteria

Exclusion criteria: severe health conditions, infective diarrhoea.

Design outcomes

Primary

MeasureTime frame
Reduction in duration of diarrhoea. Improvement in daily number and consistency of stool.Timepoint: 10-14 days—

Secondary

MeasureTime frame
Safe and tolerable treatmentTimepoint: 10 - 14 days—

Countries

India

Contacts

Public ContactDr. Manish Maladkar
scientific@aristopharma.org02226739999

Outcome results

None listed

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