Probiotics Prevent Health Problems in Children
Condition: Gastrointestinal System Disease; Respiratory System
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional

Summary: 
      Randomized controlled field trial of a probiotics to assess its roles in the prevention or
      improvement of constipation and diarrhea, acute respiratory infection, nutrition improving in
      Vietnam children.

      In the present proposal, the investigators plan to examine if daily intake of a probiotic
      beverage, which includes 6.5 billion probiotic Lactobacilli, has a beneficial role in
      protecting children from infectious diarrhea and constipation in Vietnam with 3 objectives:

        1. To assess the impact of probiotics in the prevention or improvement of diarrhea and
           constipation in children

        2. To assess the impact of probiotics in the prevention of disease of respiratory system
           (ARI)

        3. To assess the impact of probiotics on nutrition and growth of the children
    

Detailed description: 
      It will be a randomized controlled field trial involving 1036 children aged between 3 and 5
      years in some communities in Vietnam. The 1036 children will be identified through
      demographic survey. Based on available National data to determine the province - Thanh Hoa
      province
      (http://viendinhduong.vn/news/vi/106/61/0/a/so-lieu-thong-ke-ve-tinh-trang-dinh-duong-tre-em-
      qua-cac-nam.aspx), after surveying 2.000 children at least 6 communes, it is expected to give
      1036 eligible children. The study will be randomized where the treatment group will receive
      Probiotic drink, which includes 65 billion probiotic Lactobacillus casei strain Shirota, one
      bottle (65ml) daily for 12 weeks and the non-treatment arm will not receive the probiotic
      drink for 12 weeks. Randomization will be done in a ratio of 1:1, i.e., the study arm and
      control arm will include 518 children each. All the children under the study will be visited
      daily by a by teachers at kindergartens (when the children attend class), or by parents (when
      the children are at home). The surveillance persons will supervise the intake of Probiotic
      drink by the children, the status of diarrhea and constipation, disease of respiratory in
      children and recording the data every day. All the children will be followed up daily for 4
      weeks (after stop the intervention) for identification of diarrhea and constipation cases.
      Functional constipation defined by ROME III was evaluated every 4 weeks. It was diagnosed by
      doctors with reference to the logbook records. The stool consistency was recorded in a daily
      logbook based on the Bristol Stool Form Scale. Diarrhea will be defined as three or more
      abnormally loose or liquid stools within last 24 h period. Details of such diarrhea cases
      including their duration, frequency of stool, type of stool (watery or bloody), other
      associated symptoms like abdominal pain etc. will be recorded. Qualified medical doctors will
      provide services for appropriate counseling and treatment and severe cases will be referred
      to the hospital. Doctors at commune stations are collaborate to provide service for
      appropriate counseling and treatment during the time of trial. And doctors at district
      hospitals and Thanh Hoa province will be collaborated to treat with severe cases when they
      are referred to. Measurements of height, weight and mid-arm circumference will assess
      nutritional status of the children at the beginning of the study, at the end of 4, 8, 12
      weeks and (at the end of 16 weeks) follow up for 4 weeks. The outcome variables will be the
      incidence of diarrhea, constipation, disease of respiratory, nutrition status and the
      efficacy of the probiotics will be calculated by comparing the diarrhea, constipation
      incidence, disease of respiratory between the two groups at 5 different point of time (at
      baseline, the end of 4, 8, 12 weeks and 16 weeks). Nutritional improving will be compared
      similarly at baseline, the end of 4, 8, 12 weeks and 16 weeks.
    

Intervention name(s): Probiotics prevent health problems in children
Intervention type(s): Dietary Supplement
Intervention description(s): A controlled field trial was conducted with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed fermented milk 65 mL/day containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group (n=493) were not given any. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline, after 4, 8, and 12-week intervention and after the 4-week follow-up period.
Other intervention name(s): Yakult fermented milk
Intervention model: Single Group Assignment
Intervention model description: A controlled field trial was implemented with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed 65 mL/day of fermented milk containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group did not. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline and 4, 8, and 12-week of intervention and after the 4-week follow up period.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Lactobacillus casei strain Shirota; diarrhea, constipation; respiratory system; nutrition status; children 3-5 years old