Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
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|ClinicalTrials.gov Identifier: NCT04144491|
Recruitment Status : Completed
First Posted : October 30, 2019
Last Update Posted : April 28, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Respiratory Tract Infections Diarrhea Skin Diseases Tinea Capitis Common Cold||Dietary Supplement: Probiotic Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||195 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 16, 2019|
|Actual Primary Completion Date :||November 29, 2019|
|Actual Study Completion Date :||May 30, 2020|
Yoghurt, containing Lactobacillus rhamnosus yoba 2012, Streptococcus thermophilus C104, whole milk, 5% sugar, 0.1% strawberry or vanilla flavor essence.
Dietary Supplement: Probiotic
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.
Placebo Comparator: Custard
Custard, containing whole milk, 5% sugar, 0.1% strawberry or vanilla flavor essence, 4% modified corn starch.
Dietary Supplement: Placebo
100ml of custard will be consumed 5 days per week, for 9 weeks.
- The number of children on each individual day that suffers from Respiratory Tract Infections [ Time Frame: 3 months ]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
- Changes in weight of children during the study period [ Time Frame: 3 months ]To monitor changes in weight of children aged 3-6 years in Southwest Uganda who consume yoghurt containing Lactobacillus rhamnosus yoba.
- Changes in height of the children during the study period [ Time Frame: 3 months ]To monitor changes in height of children aged 3-6 years in Southwest Uganda who consume yoghurt containing Lactobacillus rhamnosus yoba.
- The number of children on each individual day that suffers from Diarrhea [ Time Frame: 3 months ]To compare the incidence of diarrhea among the children before, during and after the intervention.
- The number of children on each individual day that suffers from any form of skin diseases [ Time Frame: 3 months ]To compare the incidence of skin rashes among the children before, during and after the intervention.
- The number of children on each individual day that is absent [ Time Frame: 3 months ]To compare absenteeism as a result of sickness among the children before, during and after the intervention.
- Differences in the metabolic profile of childrens urine between baseline and after 9 weeks of intervention using 1H-Nuclear Magnetic Resonance (NMR) Spectroscopy [ Time Frame: 3 months ]To compare metabolic profile in the urine of the children before, during and after the intervention
- 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) [ Time Frame: 3 months ]To compare the microbial profile in the stool of the children before and after the intervention.
- Differences in the immune markers of childrens saliva between baseline and after 9 weeks of intervention [ Time Frame: 3 months ]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
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|Ages Eligible for Study:||3 Years to 7 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144491
|Paragon primary and nursery School|
|Kabwohe, Sheema, Uganda|
|Principal Investigator:||Remco Kort, PhD||VU Amsterdam|
|Responsible Party:||Remco Kort, Professor, VU University of Amsterdam|
|Other Study ID Numbers:||
|First Posted:||October 30, 2019 Key Record Dates|
|Last Update Posted:||April 28, 2021|
|Last Verified:||April 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Lactobacillus rhamnosus yoba 2012
Respiratory Tract Infections
Signs and Symptoms, Digestive
Respiratory Tract Diseases
RNA Virus Infections
Bacterial Infections and Mycoses
Skin Diseases, Infectious