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Randomized Controlled Field Trial of a Probiotics to Assess Its Role in Preventig Diarrhoea

NCT00534170 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2007-09-24

No results posted yet for this study

Summary

A therapeutic as well as preventive role of probiotics has been suggested from results of different studies using different probiotics that have been tested, usually lactic acid producing bacteria such as lactobacillus, bifidobacterium and streptococcus species. The supplementation of probiotics to infants may also have a prophylactic effect against acute diarrhoeal diseases.

In the present proposal, we plan to examine if daily intake of a probiotic beverage, which includes 15 billion probiotic Lactobacilli, has a beneficial role in protecting children from infectious diarrhea in Kolkata.

OBJECTIVES

Primary objectives:

1. To assess the impact of probiotics in the prevention of acute diarrhoeal diseases in children
2. To assess the impact of probiotics on nutrition and growth of the children

Secondary Objectives:

1. Reduction in duration, frequency of diarrhoea
2. Identification of pathogens causing diarrhoea
3. Examination of faecal microflora

STUDY DESIGN

It will be a double blind randomized controlled field trial involving 4000 children aged between 1 and 5 years in an urban slum of Kolkata, India. The 4000 children will be identified through demographic survey. The study will be double blinded where the study arm will receive Probiotic drink, which includes 15 billion probiotic Lactobacilli, one bottle (65ml) daily (under supervision of a Health Worker) for 12 weeks and the control arm will receive a similar drink without the lactobacilli (Nutrient drink) daily for 12 weeks. Randomization will be done in a ratio of 1:1, i.e., the study arm and control arm will include 2000 children each. All the children under the study will be visited daily by a health worker who will supervise intake of Probiotic drink or Nutrient drink by the children. All the children will be followed up daily for 24weeks for identification of acute diarrhoea cases.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic (Yakult)

It is a dietary supplement ,65 ml containing 15 billion lactobacillus

Sponsors & Collaborators

  • Yakult Honsha Co., LTD

    collaborator INDUSTRY

  • Indian Council of Medical Research

    lead OTHER_GOV

Principal Investigators

  • Dr.Dipika Sur, MD · National Institute of Cholera and Enteric Diseases, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Completion
2008-01-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534170 on ClinicalTrials.gov