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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Indian Council of Medical Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Yakult Honsha Co., LTD
Information provided by:
Indian Council of Medical Research
ClinicalTrials.gov Identifier:
NCT00534170
First received: September 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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 Intervention Phase
Diarrhea
Dietary Supplement: Probiotic (Yakult)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Indian Council of Medical Research:

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

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

Enrollment: 4000
Study Start Date: June 2007
Estimated Study Completion Date: January 2008
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Months to 59 Months
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Indian Council of Medical Research

Additional 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
Study First Received: September 21, 2007
Last Updated: September 21, 2007
Health Authority: India: Indian Council of Medical Research

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

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

ClinicalTrials.gov processed this record on October 21, 2014