Schistosomiasis/bilharziasis in preschool and school children along shores and on islands of Lake Victoria western Kenya: identifying suitable markers for monitoring the progress of bilharzia treatment
| ISRCTN | ISRCTN12844825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12844825 |
| Secondary identifying numbers | TMA2019CDF-2746 |
- Submission date
- 10/03/2022
- Registration date
- 10/05/2022
- Last edited
- 18/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Bilharzia is an infection caused by a parasitic worm that lives in fresh water in subtropical and tropical regions. To control bilharzia, the Kenyan government and its working partners distribute bilharzia medicine to schoolchildren who are known to face a high risk of bilharzia. However, increasing reports show preschool children also face a threat of suffering from bilharzia and can benefit from such bilharzia treatment programs. The World Health Organization supports the extension of bilharzia treatment plans in preschool children. There is therefore a need to have simple tools which can be used to measure the impact of such control programs upon the disease. Eosinophil cationic protein (ECP) is increasingly being used as an indicator for infection of the large intestines. Bloody stool is also a dependable pointer for large intestine disease. The aim of this study is to find out whether ECP and blood in stool can be used as signs of large intestine disease caused by bilharzia worms before and after treatment with praziquantel (bilharzia medicine).
Who can participate?
Children enrolled in early childhood development (ECD) (PP1) and grade 4 in primary schools within Mbita Health and Demographic Surveillance System, western Kenya
What does the study involve?
At the beginning of the study, selected children will be checked for bilharzia by examining their stool and urine. Those with bilharzia will be followed for 18 months. All children with bilharzia will be given bilharzia medicine according to the Kenyan ministry of health guidelines. A second treatment will be done 6 weeks after the initial treatment. This is to increase the chances of clearing the bilharzia parasite from the body. The two-dose treatment will be repeated at 6 and 18 months after baseline in all positive cases. Additionally, examination and treatment of soil-transmitted worms together with malaria will be done. Tests for hemoglobin in finger-prick blood and eosinophil cationic protein and blood in feces will done at baseline, 6 and 18 months. Additionally, other data such as age, height, weight, body temperature and medical data resulting from examination of stool, urine and blood samples will be collected.
What are the possible risks and benefits of participating?
If eosinophil cationic protein and blood in feces are found to be associated with bilharzia they can be used to monitor the effectiveness of bilharzia deworming programs. Children will be treated (free of charge) if they are found to be infected with bilharzia, intestinal worms or malaria. There are no risks involved when collecting stool or urine samples from children. A fingerprick blood sample will be drawn using safe needles. This might cause slight discomfort but there will be no risk.
Where is the study run from?
Mbita Health Demographic Surveillance System (Kenya)
When is the study starting and how long is it expected to run for?
May 2020 to May 2023
Who is funding the study?
European Union
Who is the main contact?
Dr Evans Chadeka
echadeka@kemri.go.ke
Contact information
Principal Investigator
PO Box 58840
Nairobi
00200
Kenya
 ORCID ID |
0000-0003-0811-7505 |
|---|---|
| Phone | +254 (0)742101093 |
| echadeka@kemri.go.ke |
Study information
| Study design | Observational cohort follow-up study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | School |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to a request a participant information sheet |
| Scientific title | Intestinal schistosomiasis in preschool and school children residing along shores and on islands of Lake Victoria western Kenya: investigation of eosinophil cationic protein and fecal occult blood as potential markers for schistosomiasis induced bowel morbidity |
| Study acronym | ECP$FOB |
| Study objectives | Overall, the study aims to investigate the applicability of eosinophil cationic protein (ECP) and fecal occult blood (FOB) as proxy markers of Schistosoma mansoni infection-induced intestinal morbidity before and after treatment with praziquantel. The specific objectives are: 1. Determine the prevalence of S. mansoni infection in preschool and school-aged children using parasitological (Kato-Katz) and CCA point-of-care (POC) kits methods. 2. Compare the fecal levels of eosinophil cationic protein and fecal occult blood in children not infected and those infected with S. mansoni. 3. Measure the fecal levels of eosinophil cationic protein and fecal occult blood in S. mansoni infected children pre and post treatment with praziquantel. 4. Evaluate the potential use of eosinophil cationic protein and fecal occult blood as markers for intestinal schistosomiasis-induced bowel morbidity. 5. Compare the performance of eosinophil cationic protein and fecal occult blood as potential surrogate markers in identifying S. mansoni infection-induced bowel morbidity among preschool versus school children. |
| Ethics approval(s) | Approved 05/05/2021, Kenya Medical Research Institute (KEMRI) Scientific and Ethics Research Unit (SERU, PO Box 54840 00200 Off Raila Mbagathi Road, Nairobi, Kenya; +254 (0)717719477; seru@kemri.org, kemriseru18@gmail.com), ref: SERU-4174 |
| Health condition(s) or problem(s) studied | Schistosomiasis |
| Intervention | At the beginning of the study, selected children will be checked for bilharzia by examining their stool and urine. Those with bilharzia will be followed for 18 months. All children with bilharzia will be given bilharzia medicine according to the Kenyan ministry of health guidelines. A second treatment will be done 6 weeks after the initial treatment. This is to increase the chances of clearing the bilharzia parasite from the body. The two-dose treatment will be repeated at 6 and 18 months after baseline in all positive cases. Additionally, examination and treatment of soil-transmitted worms together with malaria will be done. Tests for hemoglobin in finger-prick blood and eosinophil cationic protein and blood in feces will done at baseline, 6 and 18 months. Additionally, other data such as age, height, weight, body temperature and medical data resulting from examination of stool, urine and blood samples will be collected. |
| Intervention type | Other |
| Primary outcome measure | 1. Fecal occult blood (FOB) measured by point of care (POC) chromatographic test assessed before and after praziquantel treatment at baseline, 6 months post-baseline and end-line 2. Eosinophil cationic protein (ECP) in stool measured by ELISA assessed before and after praziquantel treatment at baseline, 6 months post-baseline and end-line |
| Secondary outcome measures | Hemoglobin levels measured by POC Hemocue machine before and after praziquantel treatment at baseline, 6 months post-baseline and end-line |
| Overall study start date | 01/05/2020 |
| Completion date | 30/05/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 481 |
| Total final enrolment | 528 |
| Key inclusion criteria | 1. Children enrolled in ECDs (PP1) and grade 4 in primary schools within Mbita Health and Demographic Surveillance System (HDSS), western Kenya 2. They should have stayed within the study site for the last 2 years and intend to stay for at least 2 more years |
| Key exclusion criteria | Those registered with other schistosomiasis studies |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 16/12/2021 |
Locations
Countries of recruitment
- Kenya
Study participating centre
Mbita
40305
Kenya
Sponsor information
Charity
PO Box 93015, 2509 AA
The Hague
51, 2593 HW
Netherlands
| Phone | +31 (0)70 344 0880 |
|---|---|
| edctpgrants@edctp.org | |
| Website | http://www.edctp.org |
"ROR" |
https://ror.org/031jv9v19 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in open peer-reviewed journal, presentations in scientific conferences and feedback meetings with local health and education authorities within the study area. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
18/03/2022: Trial's existence confirmed by the European & Developing Countries Clinical Trials Partnership.
