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

NCT03990220 | Unknown DMC

• 1 other identifier: 01/09-18
• Study Type: observational
• Target: 1,116
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

probiotics; Lactobacillus rhamnosus yoba 2012; Skin diseases; Respiratory Tract Infections; School absenteeism; Diarrhea; Anthropometric indicators

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 (5)

• 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)

Treatment

500 children, 3-6 years old attending pre-primary school in Southwest Uganda, who recently decided to start the consumption of yoghurt containing Lactobacillus rhamnosus, 100 ml per day, on any school day (i.e. monday - friday with the exception of school holidays).

Dietary Supplement: Lactobacillus rhamnosus yoba 2012

Control

500 children, 3-6 years old attending pre-primary school in Southwest Uganda, who recently decided to start the consumption of milk, 100 ml per day, on any school day (i.e. monday - friday with the exception of school holidays).

Interventions

Lactobacillus rhamnosus yoba 2012 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.

Also known as: Lactobacillus rhamnosus GG

Treatment

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children 3-6 years old attending pre-primary schools in the districts Kiruhura, Lyantonde, Sheema, Bushenyi, Mbarara, Isingiro or Ntungamo in Southwest Uganda. Children of all genders and all health statuses are enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (10)

BDA Nursery and Primary School

Ishaka, Bushenyi, Uganda

Location

Jireh Junior School

Ishaka, Bushenyi, Uganda

Location

Itojo Nusery and Primary School

Itojo, Ntungamo, Uganda

Location

Queen and King Nursery and Primary School

Itojo, Ntungamo, Uganda

Location

Blue Sight Primary School

Kabwohe, Sheema, Uganda

Location

Faith Memorial Nursery and Primary School

Bushenyi, Uganda

Location

Hanny Nusery and Primary School

Isingiro, Uganda

Location

St. Eliza Excell Nursery and Primary School

Isingiro, Uganda

Location

St. Francis Nursery and Primary School

Lyantonde, Uganda

Location

Mbarara Progressive Nursery and Primary School

Mbarara, 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

Biospecimen

Retention: NONE RETAINED

Urine Samples

MeSH Terms

Conditions

Skin Diseases; Respiratory Tract Infections; Diarrhea

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Infections; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Remco Kort, PhD

  VU Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: June 18, 2019
• Study Start: July 1, 2019
• Primary Completion: September 15, 2019
• Study Completion: June 1, 2020
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (10)