Respiratory Tract InfectionsNCT04144491
Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
A study testing Probiotic in people with Respiratory Tract Infections and Diarrhea, run by VU University of Amsterdam at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Diarrhea, Skin Diseases
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteUganda
- Study dates
- 16 Sep 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
This is a nutritional trial with two arms: 1) Intervention arm of Probiotic Yoghurt containing Lactobacillus rhamnosus yoba 2012 and 2) Placebo 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. The yoghurt and the placebo product will be locally sourced in the district where the school is located. Monitoring and data collection tools are:
- Baseline, mid line and end line questionnaire administered to parents to identify confounding factors (e.g. use of medication and diet from home) of treatment and control group.
- Weight and height measurements at baseline and end line in both the treatment and control group (total 2 times).
- Daily monitoring of the incidence of RTIs, diarrhoea, skin rashes or other diseases in treatment and control groups by a nurse, registered in a mobile application.
- Collection of urine samples every 4 weeks for 3 months (total 4 times), for assessment of impact of the intervention on system health.
- Collection of stool samples at baseline and end line, for assessment of impact of the intervention on gut health.
- Collection of saliva samples before and towards the end of the intervention, for assessment of impact of the intervention on immune biomarkers
The consumption of probiotic yoghurt at school as paid for by the parents, is currently being promoted by an Non-Governmental Organization (NGO) in the region. Following this program, children from a primary school that includes a pre-primary section, in which both the management and the parents have recently decided to purchase yoghurt for the pupils on regular basis will be recruited. The study subjects (children) are recruited at these institutions, after consent from the parent has been obtained. The parent is free to provide his/her child with yoghurt, even if the parent does not consent for the child to take part in the study.
The study will start three weeks before either yoghurt or placebo consumption commences, in order to establish a solid baseline. With the help of tablets and a specially designed mobile application, nurses will keep track of their pupils' health by tracking incidence of diarrhoea, respiratory tract infections, skin rashes and other diseases. Teachers will keep track of the daily attendance of pupils.
Measurements of weight and height will be measured by a nurse at baseline and end line. The measurements will be conducted with the help of Standard Operations Procedures as provided by Life Study and analyzed with the help of World Health Organization (WHO) guidelines. Urine samples will be taken from the children at baseline, after 4 weeks, after 8 weeks, and at end line (12 weeks). Stool samples and saliva samples will be taken at the beginning and the end of the study.
During these 3 months in which the children will be monitored, a questionnaire will be administered to the parents of the children at the start, middle and end of the study. The primary objective and content of the questionnaire is related to diet of the children outside school, in order to determine whether there are significant differences between the diets of the children in the treatment group and in the control group. The questionnaires will furthermore include questions about absenteeism and causes thereof, incidence of diarrhoea, Respiratory Tract Infections (RTI) or any other diseases, and the use of any type of drug or treatment, in order to verify and supplement the information provided by the class-teacher. Lastly, information on the vaccination history of the child will be obtained from the parent
- Being tested
- Probiotic, Placebo
- Keywords
- Lactobacillus rhamnosus yoba 2012, Children
- Medical subject headings
- Respiratory Tract Infections, Diarrhea, Skin Diseases, Tinea Capitis, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Lactobacillus rhamnosus yoba 2012, Lactobacillus rhamnosus GG
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.
PlaceboDietary supplement
100ml of custard will be consumed 5 days per week, for 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yoghurt | Experimental | Yoghurt, containing Lactobacillus rhamnosus yoba 2012, Streptococcus thermophilus C104, whole milk, 5% sugar, 0.1% strawberry or vanilla flavor essence. Receives: Dietary Supplement: Probiotic |
| Custard | Placebo comparator | Custard, containing whole milk, 5% sugar, 0.1% strawberry or vanilla flavor essence, 4% modified corn starch. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (8)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start16 Sep 2019
- Primary completion29 Nov 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Yoba for Life Foundation
- Responsible party
- Principal investigator, Remco Kort, VU University of Amsterdam
- Investigators
- Remco Kort, PhD, Principal investigator, VU Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144491
- Sponsor's protocol ID
- 01/09-19
- Status last verified
- Apr 2021
- First submitted
- 14 Sep 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dezateux, C., Williams, J., Walton, S., Wells, J., 2016. Life Study Standard Operating Procedures: Adult Anthropometry.
Williams, J., Walton, S., Wells, J., 2016. Life Study Standard Operating Procedures: Infant Anthropometry.
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
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.
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.
PubMed 17311986Petschow 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.
PubMed 16145341Scalabrin 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.
PubMed 27975116Kort 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.
PubMed 26643044Kort 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.
PubMed 23031355
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04144491
- Acronym / sponsor ID
- 01/09-19
- Keywords
- Lactobacillus rhamnosus yoba 2012, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Yoba for Life Foundation
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a nutritional trial with two arms: 1) Intervention arm of Probiotic Yoghurt containing Lactobacillus rhamnosus yoba 2012 and 2) Placebo 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. The yoghurt and the placebo product will be locally sourced in the district where the school is located. Monitoring and data collection tools are:
- Baseline, mid line and end line questionnaire administered to parents to identify confounding factors (e.g. use of medication and diet from home) of treatment and control group.
- Weight and height measurements at baseline and end line in both the treatment and control group (total 2 times).
- Daily monitoring of the incidence of RTIs, diarrhoea, skin rashes or other diseases in treatment and control groups by a nurse, registered in a mobile application.
- Collection of urine samples every 4 weeks for 3 months (total 4 times), for assessment of impact of the intervention on system health.
- Collection of stool samples at baseline and end line, for assessment of impact of the intervention on gut health.
- Collection of saliva samples before and towards the end of the intervention, for assessment of impact of the intervention on immune biomarkers
The consumption of probiotic yoghurt at school as paid for by the parents, is currently being promoted by an Non-Governmental Organization (NGO) in the region. Following this program, children from a primary school that includes a pre-primary section, in which both the management and the parents have recently decided to purchase yoghurt for the pupils on regular basis will be recruited. The study subjects (children) are recruited at these institutions, after consent from the parent has been obtained. The parent is free to provide his/her child with yoghurt, even if the parent does not consent for the child to take part in the study.
The study will start three weeks before either yoghurt or placebo consumption commences, in order to establish a solid baseline. With the help of tablets and a specially designed mobile application, nurses will keep track of their pupils' health by tracking incidence of diarrhoea, respiratory tract infections, skin rashes and other diseases. Teachers will keep track of the daily attendance of pupils.
Measurements of weight and height will be measured by a nurse at baseline and end line. The measurements will be conducted with the help of Standard Operations Procedures as provided by Life Study and analyzed with the help of World Health Organization (WHO) guidelines. Urine samples will be taken from the children at baseline, after 4 weeks, after 8 weeks, and at end line (12 weeks). Stool samples and saliva samples will be taken at the beginning and the end of the study.
During these 3 months in which the children will be monitored, a questionnaire will be administered to the parents of the children at the start, middle and end of the study. The primary objective and content of the questionnaire is related to diet of the children outside school, in order to determine whether there are significant differences between the diets of the children in the treatment group and in the control group. The questionnaires will furthermore include questions about absenteeism and causes thereof, incidence of diarrhoea, Respiratory Tract Infections (RTI) or any other diseases, and the use of any type of drug or treatment, in order to verify and supplement the information provided by the class-teacher. Lastly, information on the vaccination history of the child will be obtained from the parent
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoghurt | Experimental | Dietary Supplement: ProbioticYoghurt, containing Lactobacillus rhamnosus yoba 2012, Streptococcus thermophilus C104, whole milk, 5% sugar, 0.1% strawberry or vanilla flavor essence. |
| Custard | Placebo comparator | Dietary Supplement: PlaceboCustard, containing whole milk, 5% sugar, 0.1% strawberry or vanilla flavor essence, 4% modified corn starch. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: Lactobacillus rhamnosus yoba 2012, Lactobacillus rhamnosus GGProbiotics 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. | Dietary supplement | Yoghurt |
| Placebo100ml of custard will be consumed 5 days per week, for 9 weeks. | Dietary supplement | Custard |
Primary outcome
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
8 secondary outcomes
Changes in weight of children during the study period
Time frame: 3 months
Changes in height of the children during the study period
Time frame: 3 months
The number of children on each individual day that suffers from Diarrhea
Time frame: 3 months
The number of children on each individual day that suffers from any form of skin diseases
Time frame: 3 months
The number of children on each individual day that is absent
Time frame: 3 months
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
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
Differences in the immune markers of childrens saliva between baseline and after 9 weeks of intervention
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- BackgroundDezateux, C., Williams, J., Walton, S., Wells, J., 2016. Life Study Standard Operating Procedures: Adult Anthropometry.
- BackgroundWilliams, J., Walton, S., Wells, J., 2016. Life Study Standard Operating Procedures: Infant Anthropometry.
- BackgroundWorld 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
- BackgroundWorld 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: PubMed 17311986Pineiro 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.
- Background: PubMed 16145341Petschow 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.
- Background: PubMed 27975116Scalabrin 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.
- Background: PubMed 26643044Kort 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.
- Background: PubMed 23031355Kort 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remco Kort, PhD principal investigator
VU Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Respiratory Tract Infections and Diarrhea, run by VU University of Amsterdam at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of children on each individual day that suffers from Respiratory Tract Infections (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04144491, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.