MedTrace Logo

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

NCT03990220 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1116

Last updated 2019-12-02

No results posted yet for this study

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.

Conditions

  • Skin Diseases
  • Respiratory Tract Infections
  • Diarrhea

Interventions

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.

Sponsors & Collaborators

  • Yoba for Life Foundation

    collaborator UNKNOWN

  • VU University of Amsterdam

    lead OTHER

Principal Investigators

  • Remco Kort, PhD · VU Amsterdam

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2019-09-15
Completion
2020-06-01

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03990220 on ClinicalTrials.gov