Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
Condition: Respiratory Tract Infections; Diarrhea; Skin Diseases; Tinea Capitis; Common Cold
MeSH terms: Infections; Respiratory Tract Infections; Common Cold; Tinea Capitis; Skin Diseases; Diarrhea
Study type: Interventional

Summary: 
      This is a nutritional trial with two arms: 1) Intervention arm of Probiotic Yoghurt
      containing Lactobacillus rhamnosus yoba 2012 and 2) Control arm of custard-like dairy
      product. The study subjects are 200 children between the age of 3-6 years that attend a
      school in Southwestern Uganda, Sheema district. Children will be randomized and enrolled in
      either the yoghurt (100 children) or the placebo (100 children) arm. The children will be
      monitored for 3 weeks in the baseline in regards to the incidence of common childhood
      diseases. During these three weeks, stool, saliva and urine samples will be collected. Also
      measurement of anthropometric indicators (weight and height) will take place. Subsequently,
      the children will consume either 100ml yoghurt or 100ml placebo product, once per day for
      five days per week for nine weeks, while being daily monitored in regards to the incidence of
      common childhood diseases. The same samples (stool, urine and saliva) and assessments
      (anthropometric) will take place at end line.
    

Detailed description: 
      This is a nutritional trial with two arms: 1) Intervention arm of Probiotic Yoghurt
      containing Lactobacillus rhamnosus yoba 2012 and 2) Placebo arm of custard-like dairy
      product. The study subjects are 200 children between the age of 3-6 years that attend a
      school in Southwestern Uganda, Sheema district. Children will be randomized and enrolled in
      either the yoghurt (100 children) or the placebo (100 children) arm. The children will be
      monitored for 3 weeks in the baseline in regards to the incidence of common childhood
      diseases. During these three weeks, stool, saliva and urine samples will be collected. Also
      measurement of anthropometric indicators (weight and height) will take place. Subsequently,
      the children will consume either 100ml yoghurt or 100ml placebo product, once per day for
      five days per week for nine weeks, while being daily monitored in regards to the incidence of
      common childhood diseases. The same samples (stool, urine and saliva) and assessments
      (anthropometric) will take place at end line. The yoghurt and the placebo product will be
      locally sourced in the district where the school is located. Monitoring and data collection
      tools are:

        1. Baseline, mid line and end line questionnaire administered to parents to identify
           confounding factors (e.g. use of medication and diet from home) of treatment and control
           group.

        2. Weight and height measurements at baseline and end line in both the treatment and
           control group (total 2 times).

        3. Daily monitoring of the incidence of RTIs, diarrhoea, skin rashes or other diseases in
           treatment and control groups by a nurse, registered in a mobile application.

        4. Collection of urine samples every 4 weeks for 3 months (total 4 times), for assessment
           of impact of the intervention on system health.

        5. Collection of stool samples at baseline and end line, for assessment of impact of the
           intervention on gut health.

        6. Collection of saliva samples before and towards the end of the intervention, for
           assessment of impact of the intervention on immune biomarkers

      The consumption of probiotic yoghurt at school as paid for by the parents, is currently being
      promoted by an Non-Governmental Organization (NGO) in the region. Following this program,
      children from a primary school that includes a pre-primary section, in which both the
      management and the parents have recently decided to purchase yoghurt for the pupils on
      regular basis will be recruited. The study subjects (children) are recruited at these
      institutions, after consent from the parent has been obtained. The parent is free to provide
      his/her child with yoghurt, even if the parent does not consent for the child to take part in
      the study.

      The study will start three weeks before either yoghurt or placebo consumption commences, in
      order to establish a solid baseline. With the help of tablets and a specially designed mobile
      application, nurses will keep track of their pupils' health by tracking incidence of
      diarrhoea, respiratory tract infections, skin rashes and other diseases. Teachers will keep
      track of the daily attendance of pupils.

      Measurements of weight and height will be measured by a nurse at baseline and end line. The
      measurements will be conducted with the help of Standard Operations Procedures as provided by
      Life Study and analyzed with the help of World Health Organization (WHO) guidelines. Urine
      samples will be taken from the children at baseline, after 4 weeks, after 8 weeks, and at end
      line (12 weeks). Stool samples and saliva samples will be taken at the beginning and the end
      of the study.

      During these 3 months in which the children will be monitored, a questionnaire will be
      administered to the parents of the children at the start, middle and end of the study. The
      primary objective and content of the questionnaire is related to diet of the children outside
      school, in order to determine whether there are significant differences between the diets of
      the children in the treatment group and in the control group. The questionnaires will
      furthermore include questions about absenteeism and causes thereof, incidence of diarrhoea,
      Respiratory Tract Infections (RTI) or any other diseases, and the use of any type of drug or
      treatment, in order to verify and supplement the information provided by the class-teacher.
      Lastly, information on the vaccination history of the child will be obtained from the parent
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotics are defined by the Food and Agricultural Organization (FAO)/WHO as "live microorganisms, which when consumed in adequate amounts, confer a health benefit on the host". Lactobacillus rhamnosus GG (LGG) is the most documented probiotic bacteria, with many proven unique characteristics and therewith associated health benefits. No adverse effects of the consumption of LGG in healthy infants have been reported. The Lactobacillus rhamnosus yoba containing yoghurt drink, which is locally produced and subsequently consumed by resource-poor communities in rural Uganda has been described. The strain used in this intervention is a generic variant of LGG, called Lactobacillus rhamnosus yoba 2012. LGG is consumed as part of food all over the world, and is not a drug.
100ml of yoghurt containing Lactobacillus rhamnosus yoba 2012 will be consumed 5 days per week, for 9 weeks.; 100ml of custard will be consumed 5 days per week, for 9 weeks.
Other intervention name(s): Lactobacillus rhamnosus yoba 2012; Lactobacillus rhamnosus GG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lactobacillus rhamnosus yoba 2012; Children