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Comparing Synbiotics and Probiotics for Treating Diarrhea in Hospitalized Children: A 12-Day Study on Safety and Effectiveness

Comparison of efficacy and safety of synbiotic versus probiotic in the treatment of acute gastroenteritis in hospitalised children: A prospective, randomized, open-label, 12-day study. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090652
Enrollment
166
Registered
2025-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: A09- Infectious gastroenteritis and colitis, unspecified

Interventions

Intervention1: Probiotic (blend of lactobacillus Acidophillus, Lactobacillus Rhamnosus, Bifidobacterium Longum, Sacchromyces Boulardi): Probiotic (blend of lactobacillus Acidophillus, Lactobacillus Rh

Sponsors

Vinesh Choudhary
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with acute diarrhea admitted to in patient department & showing signs of dehydration (less than 14 days duration) Parents willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Children with persistent/chronic diarrhea 2. Children with severe malnutrition 3. Children having respiratory/systemic infection 4. Subjects who participated in any investigational drug within 30 days prior to study screening 5. Children with known hypersensitivity for synbiotic or probiotics 6. Children with chronic systemic illness 7. Parents not willing to give written inform consent

Design outcomes

Primary

MeasureTime frame
compare the reduction in frequency and duration of diarrhea after administration of synbiotic and probioticTimepoint: 0, 5th and 12th day

Secondary

MeasureTime frame
1) To assess the effects on consistency of stool 2) To evaluate adverse drug reactions of Synbiotic and Probiotic Timepoint: 1) To assess the effects on consistency of stool 2) To evaluate adverse drug reactions of Synbiotic and Probiotic on 0, 5th and 12th day

Countries

India

Contacts

Public ContactDr Vandana Avinash Badar

Indira Gandhi Government Medical College, Nagpur

drvandanabadar@yahoo.co.in9960031486

Outcome results

None listed

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