Double Blind Randomised control trail to study the role of two species Probiotics in prevention of Antibiotics Associated Diarrhoea(AAD)

Double Blind Randomised Control trail to study the role of Probiotics in prevention of Antibiotics Associated Diarrhoea(AAD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052351

Enrollment

335

Registered

2023-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: K929- Disease of digestive system, unspecified

Interventions

Intervention1: ORAL PROBIOTICS: GROUP A WILL RECEIVE MIXTURE OF LACTOBACILLUS RAHAMNOSUS GG AND SACCHAROMYCES BOULARDII ONE SACHET TWICE DAILY for duration of antibioticss (5 to 10days) Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: Children from 1 to 18yrs. Hemodynamically stable. Antibiotics adminstration planned for 5 to 10days. Ability to start probiotics within 24hrs after start of antibiotcs. Oral & parenteral antibiotics

Exclusion criteria

Exclusion criteria: Prior use of antibiotics within previous 4wks. Use of probiotics within previous 4 wks. No history suggestive of chronic illness.

Design outcomes

Primary

Measure	Time frame
To compare the proportion of children developing antibiotic associated diarrhoea (AAD) in those supplemented with two species probiotic and with placebo.Timepoint: 1st week after completion of Antibiotics. 2nd week after completion of antibiotics	—

Secondary

Measure	Time frame
To assess mean duration of diarrhoea Side effects of Probiotics Timepoint: 2 WEEKS	—

Countries

India

Contacts

Public ContactSaba Nahid Ali

Eras lucknow medical college and hospital

drchhavi.nanda@gmail.com7408737635

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026