A study to evaluate the beneficial effects of probiotics by supplementing with standard of care in the treatment of diarrhea affecting infants and children with mild to moderate dehydration.

To evaluate the efficacy of probiotic supplements for infants and children in the management of acute diarrhea in a tertiary care hospital in South India - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061278

Enrollment

100

Registered

2024-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: K639- Disease of intestine, unspecified

Interventions

Intervention1: Probiotic supplement Contains Bacillus mesentericus T-OA -1 Million Lactobacillus sporogenes - 50 Million, Streptococcus Thermophilus St-21- 100 Million, Bacillus Clausii - 2 Billion.

Eligibility

Inclusion criteria

Inclusion criteria: Children of either sex aged 6 months to 5 years suffering from acute diarrhea with moderate dehydration (duration

Exclusion criteria

Exclusion criteria: Children with history of malabsorption syndromes. Having respiratory infections / systemic infection. Children with hypersensitivity to any of the components

Design outcomes

Primary

Measure	Time frame
Measure of Number of episodes (frequency) of diarrhea in a day Mean duration of diarrhea (in days) Duration and volume of oral rehydration salt [ORS] therapy Duration and volume of intravenous fluid [IVF] therapy Consistency of stool by Bristol stool scale. Timepoint: 5 days study period	—

Secondary

Measure	Time frame
secondary outcome will be assessed by the occurrence of adverse events (if worsening of existing symptoms, hypersensitivity reactions) following the administration of probiotics and if any will be notified to the IPC and will be uploaded in Vigiflow. Parental satisfaction on a Likert scale through parental interviews after examining their daily records will be maintained in the diaryTimepoint: 5 days study period	—

Measure

Time frame

secondary outcome will be assessed by the occurrence of adverse events (if worsening of existing symptoms, hypersensitivity reactions) following the administration of probiotics and if any will be notified to the IPC and will be uploaded in Vigiflow. Parental satisfaction on a Likert scale through parental interviews after examining their daily records will be maintained in the diaryTimepoint: 5 days study period

—

Countries

India

Contacts

Public ContactDr Elavarasi R

CHENGALPATTU MEDICAL COLLEGE

vijayapaed@gmail.com9444728805

Outcome results

None listed

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