NCT00534170

Brief 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. 1.To assess the impact of probiotics in the prevention of acute diarrhoeal diseases in children
  2. 2.To assess the impact of probiotics on nutrition and growth of the children
  3. 3.Reduction in duration, frequency of diarrhoea
  4. 4.Identification of pathogens causing diarrhoea
  5. 5.Examination of faecal microflora

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

September 24, 2007

Status Verified

June 1, 2007

First QC Date

September 21, 2007

Last Update Submit

September 21, 2007

Conditions

Diarrhea

Keywords

ProbioticPrevention of diarrhoeaNutritional status

Outcome Measures

Primary Outcomes (1)

  • Diarrhoeal episodes in children

    10 months

Secondary Outcomes (1)

  • nutritional status in children

    10 months

Study Arms (1)

A,F,T,K

EXPERIMENTAL

Two arms are for intervention and two are for control or placebo

Dietary Supplement: Probiotic (Yakult)

Interventions

Probiotic (Yakult)DIETARY_SUPPLEMENT

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

Also known as: Yakult
A,F,T,K

Eligibility Criteria

Age12 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children of either sex aged 1-5 years will be eligible for screening and parents will give and a written, informed consent form will be required from either of the parents/ guardians of each participating child.
  • Participating children should be free from any chronic illness and also any recent illness that may compromise the immune system. In general they will have good health without known underlying illness

You may not qualify if:

  • Children below -2SD of the National Center for Health Statistics (NCHS) reference median in the nutritional parameters will not be enrolled.
  • Children with history of diarrhoea in the preceding 2 weeks will not be eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cholera and Enteric Disease

Kolkata, West Bengal, 7000010, India

Location

Related Publications (1)

  • Sur D, Manna B, Niyogi SK, Ramamurthy T, Palit A, Nomoto K, Takahashi T, Shima T, Tsuji H, Kurakawa T, Takeda Y, Nair GB, Bhattacharya SK. Role of probiotic in preventing acute diarrhoea in children: a community-based, randomized, double-blind placebo-controlled field trial in an urban slum. Epidemiol Infect. 2011 Jun;139(6):919-26. doi: 10.1017/S0950268810001780. Epub 2010 Jul 30.

    PMID: 20670468DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Dr.Dipika Sur, MD

    National Institute of Cholera and Enteric Diseases, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 21, 2007

First Posted

September 24, 2007

Study Start

June 1, 2007

Study Completion

January 1, 2008

Last Updated

September 24, 2007

Record last verified: 2007-06

Locations

IN(1)