A Nutritional Trial on Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda

A Nutritional Trial on Effect of Probiotic Yoghurt Containing Lactobacillus Rhamnosus Yoba 2012 on Respiratory Tract Infection and Other Health Outcomes Among Children Aged 3-6 Years in Southwest Uganda

This is a nutritional observational trial with two arms: 1) Intervention arm of Probiotic Yoghurt containing Lactobacillus rhamnosus yoba 2012 and 2) Control arm of milk. About 500 children in each arm will be enrolled. Children will be enrolled in the yoghurt or the milk arm, based on the preference of the school and the parents in response to a sensitization campaign of a non-governmental organization (NGO) in the region. This selection will therefore be non-randomized and non-blinded. Within one school, all children will be enrolled in the same arm. The children will be monitored for 3 weeks in the baseline. Subsequently, the children will consume either 100ml of yoghurt or 100ml of milk, once per day for five days per week for nine weeks, while being continuously monitored. The milk and the yoghurt will be locally sourced in the district where the schools are located.

Study Overview

• Status: Unknown
• Conditions: Skin Diseases; Respiratory Tract Infections; Diarrhea
• Intervention / Treatment: Dietary supplement: Lactobacillus rhamnosus yoba 2012

Detailed Description

This is an observational nutritional trial with two arms: 1) Intervention arm of Probiotic Yoghurt containing Lactobacillus rhamnosus yoba 2012 and 2) Control arm of milk. About 500 children in each arm will be enrolled. Children will be enrolled in the yoghurt or the milk arm, based on the preference of the school and the parents in response to a sensitization campaign of an NGO in the region. This selection will therefore be non-randomized and non-blinded. Within one school, all children will be enrolled in the same arm. The children will be monitored for 3 weeks in the baseline. Subsequently, the children will consume either 100ml of yoghurt or 100ml of milk, once per day for five days per week for nine weeks, while being continuously monitored. The milk and the yoghurt will be locally sourced in the district where the schools are located. Monitoring and data collection tools include:

1. Baseline, midline 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, height, mid-upper-arm circumference MUAC and head circumference measurements every 4 weeks for 3 months in both the treatment and control groups (total 4 times). One point measurement will be taken 6 months after the study.
3. Daily monitoring of the incidence of RTIs, diarrhoea, skin rashes or other diseases in treatment and control groups by teachers with confirmation of a nurse in a mobile app.

Children from pre-primary institutions in which both the management and the parents have recently decided to purchase either milk or yoghurt for the pupils on regular basis will be recruited. The study subjects (children) are recruited at these institutions. Only children from parents who have agreed to contribute to the consumption of milk / yoghurt and who have furthermore consented for their children to be measured and monitored for the purpose of the current study will be recruited. The parent is free to provide his/her child with milk / 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 milk or yoghurt consumption commences, in order to establish a solid baseline. With the help of tablets and a specially designed app, 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, height, MUAC and head circumference will be measured by a nurse every four weeks, starting three weeks prior to the start of the consumption of either milk or yoghurt. The measurements will be conducted with the help of Standard Operations Procedures as provided by Life Study and analysed with the help of World Health Organization (WHO) guidelines.

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 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.

• Study Type: Observational
• Enrollment (Actual): 1116

Contacts and Locations

Study Locations

• Uganda
  • Bushenyi, Uganda
    • Faith Memorial Nursery and Primary School
  • Isingiro, Uganda
    • Hanny Nusery and Primary School
  • Isingiro, Uganda
    • St. Eliza Excell Nursery and Primary School
  • Lyantonde, Uganda
    • St. Francis Nursery and Primary School
  • Mbarara, Uganda
    • Mbarara Progressive Nursery and Primary School
  • Bushenyi
    • Ishaka, Bushenyi, Uganda
      • BDA Nursery and Primary School
    • Ishaka, Bushenyi, Uganda
      • Jireh Junior School
  • Ntungamo
    • Itojo, Ntungamo, Uganda
      • Itojo Nusery and Primary School
    • Itojo, Ntungamo, Uganda
      • Queen and King Nursery and Primary School
  • Sheema
    • Kabwohe, Sheema, Uganda
      • Blue Sight Primary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children 3-6 years old attending pre-primary schools in the districts Kiruhura, Lyantonde, Sheema, Bushenyi, Mbarara, Isingiro or Ntungamo in Southwest Uganda. Children of all genders and all health statuses are enrolled.

Description

Inclusion Criteria:

• During interactions with the pre-primary institutions prior to the study, the parents of the children have agreed to pay for their child to either take milk or probiotic yoghurt (100ml five times per week).
• Parents are willing to provide written consent for their child to participate in the study, and children are willing to provide assent

Exclusion Criteria:

• The child does not comply with the inclusion criteria
• The child has an aversion against yoghurt or milk
• The child is lactose-intolerant as indicated by the parent, or has any other medical condition that will prevent him/her from taking yoghurt or milk.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; 500 children, 3-6 years old attending pre-primary school in Southwest Uganda, who recently decided to start the consumption of yoghurt containing Lactobacillus rhamnosus, 100 ml per day, on any school day (i.e. monday - friday with the exception of school holidays).	Dietary supplement: Lactobacillus rhamnosus yoba 2012; 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.; Other Names: Lactobacillus rhamnosus GG
Control; 500 children, 3-6 years old attending pre-primary school in Southwest Uganda, who recently decided to start the consumption of milk, 100 ml per day, on any school day (i.e. monday - friday with the exception of school holidays).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of children on each individual day that suffers from Respiratory Tract Infections	To compare the incidence of respiratory tract infections among children aged 3-6 years in Southwest Uganda before, during and after an intervention with probiotic yoghurt containing Lactobacillus rhamnosus yoba	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight of children during the study period	To monitor changes in weight of children aged 3-6 years in Southwest Uganda who consume yoghurt containing Lactobacillus rhamnosus yoba.	3 months
Changes in height of the children during the study period	To monitor changes in height of children aged 3-6 years in Southwest Uganda who consume yoghurt containing Lactobacillus rhamnosus yoba.	3 months
The number of children on each individual day that suffers from Diarrhea	To compare the incidence of diarrhea among the children before, during and after the intervention.	3 months
The number of children on each individual day that suffers from any form of skin diseases	To compare the incidence of skin diseases among the children before, during and after the intervention.	3 months
The number of children on each individual day that is Absent	To compare absenteeism as a result of sickness among the children before, during and after the intervention.	3 months

Collaborators and Investigators

• Sponsor: VU University of Amsterdam
• Collaborators: Yoba for Life Foundation
• Investigators: Principal Investigator: Remco Kort, PhD, VU Amsterdam

Publications and helpful links

General Publications

• Dezateux, C., Williams, J., Walton, S., Wells, J., 2016. Life Study Standard Operating Procedures: Adult Anthropometry.
• Williams, J., Walton, S., Wells, J., 2016. Life Study Standard Operating Procedures: Infant Anthropometry.
• World Health Organization (Ed.), 2007. WHO child growth standards: head circumference-for-age, arm circumference-for-age, triceps skinfold-for-age and subscapular skinfold-for-age: methods and development. World Health Organization, Geneva
• World Health Organization (Ed.), 2006. WHO child growth standards: length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age ; methods and development. WHO Press, Geneva.
• Pineiro M, Stanton C. Probiotic bacteria: legislative framework-- requirements to evidence basis. J Nutr. 2007 Mar;137(3 Suppl 2):850S-3S. doi: 10.1093/jn/137.3.850S.
• Petschow BW, Figueroa R, Harris CL, Beck LB, Ziegler E, Goldin B. Effects of feeding an infant formula containing Lactobacillus GG on the colonization of the intestine: a dose-response study in healthy infants. J Clin Gastroenterol. 2005 Oct;39(9):786-90. doi: 10.1097/01.mcg.0000177245.53753.86.
• Scalabrin D, Harris C, Johnston WH, Berseth CL. Long-term safety assessment in children who received hydrolyzed protein formulas with Lactobacillus rhamnosus GG: a 5-year follow-up. Eur J Pediatr. 2017 Feb;176(2):217-224. doi: 10.1007/s00431-016-2825-4. Epub 2016 Dec 15.
• Kort R, Westerik N, Mariela Serrano L, Douillard FP, Gottstein W, Mukisa IM, Tuijn CJ, Basten L, Hafkamp B, Meijer WC, Teusink B, de Vos WM, Reid G, Sybesma W. A novel consortium of Lactobacillus rhamnosus and Streptococcus thermophilus for increased access to functional fermented foods. Microb Cell Fact. 2015 Dec 8;14:195. doi: 10.1186/s12934-015-0370-x.
• Kort R, Sybesma W. Probiotics for every body. Trends Biotechnol. 2012 Dec;30(12):613-5. doi: 10.1016/j.tibtech.2012.09.002. Epub 2012 Sep 29. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): September 15, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 12, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 29, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Diarrhea; probiotics; Respiratory Tract Infections; Lactobacillus rhamnosus yoba 2012; Skin diseases; School absenteeism; Anthropometric indicators
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Signs and Symptoms, Digestive; Infections; Diarrhea; Skin Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 01/09-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Data will be uploaded to the online respiratory of the app as developed by Omnitech. This data will only be accessible to the researchers who have been granted the password. Besides, data will be primarily entered in excel, and analysed with the help of Statistical Package for Social Sciences (SPSS). Data will be cross validated by the different researchers involved. Data will be handled confidentially and anonymously, provided with a code and will be only accessible to the researchers.

The data collection app will create monthly health reports, which will be shared with parents to enable them to closely monitor the health and development of their children.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No