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Immunomodulatory Effect of Probiotic Strains In Indian Children

To Study Colonization & Immunomodulatory Effect of Probiotic Strains In Indian Children - CAIPIC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/004014
Enrollment
120
Registered
2013-09-23
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- Age between 1 day to 5 Year

Interventions

Intervention1: L rhamnosus L plantarum: Frequency: 1 X 109 CFU - Once in a day (OD) Total duration of therapy: - 5 days Route of administration:- Oral Control Intervention1: Placebo: Placebo

Sponsors

Department of Biotechnology Ministry of Science and Technology Govt of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants and children aged Those who would be admitted for at least 7 days

Exclusion criteria

Exclusion criteria: Prior history of probiotic intake within 6 weeks The information of prior probiotic intake will be checked from prescription slips and the drugs carried by the patients. Patients on steroids

Design outcomes

Primary

MeasureTime frame
Assessment of in vivo colonization of two ProbioticTimepoint: Assessment of in vivo colonization of two Probiotic

Secondary

MeasureTime frame
To monitor the levels of cytokines (IL-1, IL-6, IL-10 and TNF-alpha) in Stool samples of subjects, before and after intervention. To analyze the expression of Immunoglobulin receptors (IgG & IgA) on colonocytes isolated from stool before and after intervention by Flowcytometry. Timepoint: To monitor the levels of cytokines (IL-1, IL-6, IL-10 and TNF-alpha) in Stool samples of subjects, before and after intervention. To analyze the expression of Immunoglobulin receptors (IgG & IgA) on colonocytes isolated from stool before and after intervention by Flowcytometry.

Countries

India

Contacts

Public ContactDr Rama Chaudhry

All India Institute of Medical Sciences

shinjini.bhatnagar@gmail.com

Outcome results

None listed

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