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

NCT04144491 | Completed DMC

• 1 other identifier: 01/09-19
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Tract Infections; Diarrhea; Skin Diseases; Tinea Capitis; Common Cold

Keywords

Lactobacillus rhamnosus yoba 2012; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in weight of children during the study period

  3 months

• Changes in height of the children during the study period

  3 months

• The number of children on each individual day that suffers from Diarrhea

  3 months

• The number of children on each individual day that suffers from any form of skin diseases

  3 months

• The number of children on each individual day that is absent

  3 months

Study Arms (2)

Yoghurt

EXPERIMENTAL

Yoghurt, containing Lactobacillus rhamnosus yoba 2012, Streptococcus thermophilus C104, whole milk, 5% sugar, 0.1% strawberry or vanilla flavor essence.

Dietary Supplement: Probiotic

Custard

PLACEBO COMPARATOR

Custard, containing whole milk, 5% sugar, 0.1% strawberry or vanilla flavor essence, 4% modified corn starch.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Also known as: Lactobacillus rhamnosus yoba 2012, Lactobacillus rhamnosus GG

Yoghurt

Placebo DIETARY_SUPPLEMENT

100ml of custard will be consumed 5 days per week, for 9 weeks.

Custard

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VU University of Amsterdam: lead
• Yoba for Life Foundation: collaborator

Study Sites (1)

Paragon primary and nursery School

Kabwohe, Sheema, Uganda

Location

Related Publications (9)

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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17311986 BACKGROUND

• 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.

  PMID: 16145341 BACKGROUND

• 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.

  PMID: 27975116 BACKGROUND

• 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.

  PMID: 26643044 BACKGROUND

• 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.

  PMID: 23031355 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections; Diarrhea; Skin Diseases; Tinea Capitis; Common Cold

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Scalp Dermatoses; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Remco Kort, PhD

  VU Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: October 30, 2019
• Study Start: September 16, 2019
• Primary Completion: November 29, 2019
• Study Completion: May 30, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)