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

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ClinicalTrials.gov Identifier: NCT00534170
Recruitment Status : Unknown
Verified June 2007 by Indian Council of Medical Research.
Recruitment status was:  Active, not recruiting
First Posted : September 24, 2007
Last Update Posted : September 24, 2007
Sponsor:
Collaborator:
Yakult Honsha Co., LTD
Information provided by:
Indian Council of Medical Research

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. 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.


Condition or disease Intervention/treatment Phase
Diarrhea Dietary Supplement: Probiotic (Yakult) Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Field Trial of a Probiotics to Assess Its Role in The Prevention of Acute Diarrhoeal Diseases in Children
Study Start Date : June 2007
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A,F,T,K
Two arms are for intervention and two are for control or placebo
Dietary Supplement: Probiotic (Yakult)
It is a dietary supplement ,65 ml containing 15 billion lactobacillus
Other Name: Yakult



Primary Outcome Measures :
  1. Diarrhoeal episodes in children [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. nutritional status in children [ Time Frame: 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534170


Locations
India
National Institute of Cholera and Enteric Disease
Kolkata, West Bengal, India, 7000010
Sponsors and Collaborators
Indian Council of Medical Research
Yakult Honsha Co., LTD
Investigators
Principal Investigator: Dr.Dipika Sur, MD National Institute of Cholera and Enteric Diseases, India

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00534170     History of Changes
Other Study ID Numbers: YH-001 NICED 010
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: September 24, 2007
Last Verified: June 2007

Keywords provided by Indian Council of Medical Research:
Probiotic
Prevention of diarrhoea
Nutritional status

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms