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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03990220
• Other study ID #: 01/09-18
• Status: Active, not recruiting
• Start date: July 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2019
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1116
• Est. completion date: June 1, 2020
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Infection
• Respiratory Tract Infections
• Skin Diseases

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
VU University of Amsterdam	Yoba for Life Foundation

Country where clinical trial is conducted

Uganda, 

References & Publications (9)

Dezateux, C., Williams, J., Walton, S., Wells, J., 2016. Life Study Standard Operating Procedures: Adult Anthropometry.

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Williams, J., Walton, S., Wells, J., 2016. Life Study Standard Operating Procedures: Infant Anthropometry.

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.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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