ROLE OF PROBIOTICS IN MANAGEMENT OF ACUTE DIARRHOEA IN CHILDREN LESS THAN 5 YEARS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/10/002067

Enrollment

200

Registered

2011-10-14

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: null- All children aged between 6 months to 5 years with acute diarrhoea ( 7 days duration) visiting the outpatient department or emergency wards will be eligible for inclusion in the study.

Interventions

Intervention1: Probiotic Lactobacillus GG: It is food supplement.It is given at dose of 10 billion CFU/day, given orally once a day for 5 days. Control Intervention1: No probiotic: it is compared to t

Eligibility

Inclusion criteria

Inclusion criteria: All children aged between 6 months to 5 years with acute diarrhoea (less than 14 days duration) visiting the outpatient department (OPD) or emergency wards will be eligible for inclusion in the study. Diarrhoea will be defined if child is having three or more loose stools in the last 24 hours.

Exclusion criteria

Exclusion criteria: 1. Severe malnutrition (Weight for length 3 SD) 2. Dysentery (Presence of visible blood in stools) 3. Clinical evidence of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia) 4. Clinical evidence of chronic disease (e.g. chronic liver disease, chronic renal disease, nephrotic syndrome) 5. Known case of chronic gastrointestinal diseases like celiac disease or inflammatory bowel disease. 6. Use of probiotics in the previous three weeks 7. Use of antibiotics or any antidiarrhoeal medication for the current episode of diarrhoea.

Design outcomes

Primary

Measure	Time frame
1. Duration of diarrhoea (time in hours from enrolment to the last abnormal (loose or liquid) stool. Last abnormal stool will be defined when the child passes normal stool or no stool for next 24 hours. 2. Stool consistency as evaluated on a score. Faeces will be graded as 1 (normal), 2 (loose), 3 (semiliquid), and 4 (liquid)5. Timepoint: probiotic lactobacillus GG given for 5 days at the dose of 10 billion CFU/day	—

Measure

Time frame

1. Duration of diarrhoea (time in hours from enrolment to the last abnormal (loose or liquid) stool. Last abnormal stool will be defined when the child passes normal stool or no stool for next 24 hours. 2. Stool consistency as evaluated on a score. Faeces will be graded as 1 (normal), 2 (loose), 3 (semiliquid), and 4 (liquid)5. Timepoint: probiotic lactobacillus GG given for 5 days at the dose of 10 billion CFU/day

—

Secondary

Measure	Time frame
1. Number of loose stools per day during entire episode. 2. Duration of vomiting. 3. Duration of hospital stay. 4.Any adverse effects Timepoint: patients is monitored till his diarrhoea is relieved	—

Countries

India

Contacts

Public ContactDr Amit Upadhyay

Lala Lajpat Rai Memorial Medical College, Meerut

anuamit7@rediffmail.com9837405009

Outcome results

None listed

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