Role of Probiotics on growth and diarrhea in children

To study the effect of L. paracasei Lpc-37 or B. lactis Bi-07 supplementation for 10 months period, on diarrheal morbidity, febrile episodes, immune function, nutritional status and gut flora in apparently normal children.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/08/002942

Enrollment

360

Registered

2012-08-31

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

None listed

Interventions

Intervention1: L. paracasei Lpc-37: at a dose of 2-5x10 9 colony forming unit per day. for a period of 10 months. Intervention2: B. lactis Bi-07: at a dose of 2-5x10 9 colony forming unit per day. fo

Eligibility

Inclusion criteria

Inclusion criteria: children aged 3-5 years, Parents willing to add a probiotic supplement or placebo each day for 10 months will be included in the study.

Exclusion criteria

Exclusion criteria: Children with major congenital birth deformities, acute illness at enrollment, or chronic conditions affecting food intake or metabolism, Participation in another clinical study, Infants from multiple gestation births (since only one child per family will be included in the study, incorporating a child from a multiple birth would add unnecessary burden to parents by requiring them to administer different formulas to different children), past history with surgical operation of gastrointestinal tracts, Antibiotic therapy prior to enrollment, Evidence or suspicion of clinical sepsis before randomization will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Reduction in Diarrhoea prevalenceTimepoint: Everyday Recall	—

Secondary

Measure	Time frame
Effect of probiotics on weight gain and linear growthTimepoint: monthly weight gain	—

Countries

Finland, India

Contacts

Public ContactDr R HEMALATHA

NATIONAL INSTITUTE OF NUTRITION

rhemalathanin@yahoo.com040-27191297

Outcome results