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
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.
- To assess the impact of probiotics in the prevention of acute diarrhoeal diseases in children
- To assess the impact of probiotics on nutrition and growth of the children
- Reduction in duration, frequency of diarrhoea
- Identification of pathogens causing diarrhoea
- Examination of faecal microflora
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- Diarrhoeal episodes in children [ Time Frame: 10 months ]
- nutritional status in children [ Time Frame: 10 months ]
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
|National Institute of Cholera and Enteric Disease|
|Kolkata, West Bengal, India, 7000010|
|Principal Investigator:||Dr.Dipika Sur, MD||National Institute of Cholera and Enteric Diseases, India|