Skin DiseasesNCT03990220
A Nutritional Trial on Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
An observational study of Skin Diseases and Respiratory Tract Infections, run by VU University of Amsterdam at 10 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases, Respiratory Tract Infections, Diarrhea
- What is being tested?
- Lactobacillus rhamnosus yoba 2012
- How many people
- 1,116 participants
- Where
- 10 sitesUganda
- Study dates
- 1 Jul 2019to 1 Jun 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- The child does not comply with the inclusion criteria
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Uganda10 sites
Faith Memorial Nursery and Primary School
Bushenyi
BDA Nursery and Primary School
Ishaka, Bushenyi
Jireh Junior School
Ishaka, Bushenyi
Hanny Nusery and Primary School
Isingiro
St. Eliza Excell Nursery and Primary School
Isingiro
Itojo Nusery and Primary School
Itojo, Ntungamo
Queen and King Nursery and Primary School
Itojo, Ntungamo
Blue Sight Primary School
Kabwohe, Sheema
St. Francis Nursery and Primary School
Lyantonde
Mbarara Progressive Nursery and Primary School
Mbarara
About this study
Official title: A Nutritional Trial on Effect of Probiotic Yoghurt Containing Lactobacillus Rhamnosus Yoba 2012 on Respiratory Tract Infection and Other Health Outcomes Among Children Aged 3-6 Years in Southwest Uganda
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.
Read the detailed description
This is an observational nutritional 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 an 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. Monitoring and data collection tools include:
- Baseline, midline 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, height, mid-upper-arm circumference MUAC and head circumference measurements every 4 weeks for 3 months in both the treatment and control groups (total 4 times). One point measurement will be taken 6 months after the study.
- Daily monitoring of the incidence of RTIs, diarrhoea, skin rashes or other diseases in treatment and control groups by teachers with confirmation of a nurse in a mobile app.
Children from pre-primary institutions in which both the management and the parents have recently decided to purchase either milk or yoghurt for the pupils on regular basis will be recruited. The study subjects (children) are recruited at these institutions. Only children from parents who have agreed to contribute to the consumption of milk / yoghurt and who have furthermore consented for their children to be measured and monitored for the purpose of the current study will be recruited. The parent is free to provide his/her child with milk / 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 milk or yoghurt consumption commences, in order to establish a solid baseline. With the help of tablets and a specially designed app, 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, height, MUAC and head circumference will be measured by a nurse every four weeks, starting three weeks prior to the start of the consumption of either milk or yoghurt. The measurements will be conducted with the help of Standard Operations Procedures as provided by Life Study and analysed with the help of World Health Organization (WHO) guidelines.
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 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.
- Conditions
- Skin Diseases, Respiratory Tract Infections, Diarrhea
- Being tested
- Lactobacillus rhamnosus yoba 2012
- Keywords
- probiotics, Lactobacillus rhamnosus yoba 2012, Skin diseases, Respiratory Tract Infections, School absenteeism, Diarrhea, Anthropometric indicators
- Medical subject headings
- Skin Diseases, Respiratory Tract Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus yoba 2012Dietary supplement
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
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 (5)
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 diseases 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start1 Jul 2019
- Primary completion15 Sep 2019
- Study completion1 Jun 2020 (estimated)
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 Skin DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,116 participants (actual)
- Target duration
- 3 Months
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
- NCT03990220
- Sponsor's protocol ID
- 01/09-18
- Status last verified
- Nov 2019
- First submitted
- 12 May 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be uploaded to the online respiratory of the app as developed by Omnitech. This data will only be accessible to the researchers who have been granted the password. Besides, data will be primarily entered in excel, and analysed with the help of Statistical Package for Social Sciences (SPSS). Data will be cross validated by the different researchers involved. Data will be handled confidentially and anonymously, provided with a code and will be only accessible to the researchers. The data collection app will create monthly health reports, which will be shared with parents to enable them to closely monitor the health and development of their children.
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 2 Dec 2019. 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 2012 on Respiratory Tract Infection and Other Health Outcomes Among Children Aged 3-6 Years in Southwest Uganda
- ClinicalTrials.gov ID
- NCT03990220
- Acronym / sponsor ID
- 01/09-18
- Conditions
- Skin Diseases, Respiratory Tract Infections, Diarrhea
- Keywords
- probiotics, Lactobacillus rhamnosus yoba 2012, Skin diseases, Respiratory Tract Infections, School absenteeism, Diarrhea, Anthropometric indicators
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,116 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Yoba for Life Foundation
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 18 Jun 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 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.
Detailed description
This is an observational nutritional 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 an 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. Monitoring and data collection tools include:
- Baseline, midline 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, height, mid-upper-arm circumference MUAC and head circumference measurements every 4 weeks for 3 months in both the treatment and control groups (total 4 times). One point measurement will be taken 6 months after the study.
- Daily monitoring of the incidence of RTIs, diarrhoea, skin rashes or other diseases in treatment and control groups by teachers with confirmation of a nurse in a mobile app.
Children from pre-primary institutions in which both the management and the parents have recently decided to purchase either milk or yoghurt for the pupils on regular basis will be recruited. The study subjects (children) are recruited at these institutions. Only children from parents who have agreed to contribute to the consumption of milk / yoghurt and who have furthermore consented for their children to be measured and monitored for the purpose of the current study will be recruited. The parent is free to provide his/her child with milk / 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 milk or yoghurt consumption commences, in order to establish a solid baseline. With the help of tablets and a specially designed app, 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, height, MUAC and head circumference will be measured by a nurse every four weeks, starting three weeks prior to the start of the consumption of either milk or yoghurt. The measurements will be conducted with the help of Standard Operations Procedures as provided by Life Study and analysed with the help of World Health Organization (WHO) guidelines.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Dietary Supplement: Lactobacillus rhamnosus yoba 2012500 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). |
| 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). |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- The child does not comply with the inclusion criteria
- 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.
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 |
|---|---|---|
| Lactobacillus rhamnosus yoba 2012Also: 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. | Dietary supplement | Treatment |
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
5 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- 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. Data will be uploaded to the online respiratory of the app as developed by Omnitech. This data will only be accessible to the researchers who have been granted the password. Besides, data will be primarily entered in excel, and analysed with the help of Statistical Package for Social Sciences (SPSS). Data will be cross validated by the different researchers involved. Data will be handled confidentially and anonymously, provided with a code and will be only accessible to the researchers. The data collection app will create monthly health reports, which will be shared with parents to enable them to closely monitor the health and development of their children.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases and Respiratory Tract Infections, run by VU University of Amsterdam at 10 sites 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 2 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: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. 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?
Results are not available in the source record.
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 NCT03990220, 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 2 Dec 2019.