Diarrhea Clinical Trial
Official title:
A Nutritional Trial on Effect of Probiotic Yoghurt Containing Lactobacillus Rhamnosus Yoba on Respiratory Tract Infection and Other Health Outcomes Among Children Aged 3-6 Years in Southwest Uganda
Verified date | April 2021 |
Source | VU University of Amsterdam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 195 |
Est. completion date | May 30, 2020 |
Est. primary completion date | November 29, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 7 Years |
Eligibility | Inclusion Criteria: - Children of a pre-primary institution in Southwest Uganda are targetted - 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 probiotic yoghurt (100ml five times per week). - Parents are willing to provide written consent for their child to participate in the study Exclusion Criteria: - The child does not comply with the inclusion criteria - The child has an aversion against yoghurt or milk products - 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 products |
Country | Name | City | State |
---|---|---|---|
Uganda | Paragon primary and nursery School | Kabwohe | Sheema |
Lead Sponsor | Collaborator |
---|---|
VU University of Amsterdam | Yoba for Life Foundation |
Uganda,
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
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 rashes 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 | |
Secondary | Differences in the metabolic profile of childrens urine between baseline and after 9 weeks of intervention using 1H-Nuclear Magnetic Resonance (NMR) Spectroscopy | To compare metabolic profile in the urine of the children before, during and after the intervention | 3 months | |
Secondary | Differences in the microbial profile of childrens stool between baseline and after 9 weeks of intervention using Next Generation Sequencing (NGS) in combination with Fluorescence In Situ Hybridisation hyphenated to Flow Cytometry (Flow-FISH) | To compare the microbial profile in the stool of the children before and after the intervention. | 3 months | |
Secondary | Differences in the immune markers of childrens saliva between baseline and after 9 weeks of intervention | To compare immune markers (secretory immunoglobulin A (IgA), secretory leukoprotease inhibitor (SLPI), immunoglobulin M (IgM), immunoglobulin G (IgG), cytokines chemokines and growth factors) in the saliva of the children before and after the intervention | 3 months |
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