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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05868551
Other study ID # AID 011898
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Universiteit Antwerpen
Contact Robert Colebunders, MD
Phone +32486920149
Email robert.colebunders@uantwerpen.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is an exploratory case control study with the aim to compare the Onchocerca volvulus virome between persons with onchocerciasis-associated epilepsy (OAE) and persons with onchocerciasis but without epilepsy. The main question we want to address is: Is there a virus contained in the O. volulus worm that may have a pathogenic role in causing OAE. In Maridi County, South Sudan, 20 persons with OAE with onchocerciasis nodules, and 20 age- and village-matched controls without OAE will be enrolled in a nodulectomy study.The adult O. volvulus worms will be extracted from the nodules and a viral metagenomic study of the worms. The O. volvulus virome of persons with and without OAE will be compared.


Description:

A high prevalence of onchocerciasis-associated epilepsy (OAE) has been observed in onchocerciasis-endemic areas with high ongoing Onchocerca volvulus transmission. However, the pathogenesis of OAE remains to be elucidated. We hypothesise that the O. volvulus virome could be involved in inducing epilepsy. With this study, we aim to describe the O. volvulus virome and identify possible viruses linked to OAE. In Maridi County, South Sudan, 20 persons with OAE with onchocerciasis nodules, and 20 age- and village-matched controls without OAE will be enrolled in the study. For each study participant, two skin snips at the iliac crest will be obtained to collect O. volvulus microfilaria, and one nodulectomy will be performed to obtain adult worms. A viral metagenomic study will be conducted on microfilariae and adult worms, and the O. volvulus virome of persons with and without OAE will be compared. Moreover, the prevalence, numbers and localisation of onchocerciasis nodules in persons with and without OAE in villages with a high prevalence of epilepsy in Maridi will be described.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers
Gender All
Age group 12 Years to 35 Years
Eligibility Inclusion Criteria: - Onchocerciasis nodules - Age 12-35 years old - informed consent signed - Living in Maridi County, Western Equatorial State, South Sudan Exclusion Criteria: - below the age of 12

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
nodulectomy
incision in an onchocerciasis nodule to extract adult worms

Locations

Country Name City State
South Sudan Amref Health Africa Juba Central

Sponsors (2)

Lead Sponsor Collaborator
Universiteit Antwerpen Amref Health Africa

Country where clinical trial is conducted

South Sudan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The O. volvulus virome of persons with onchocerciasis-associated epilepsy (OAE) and of persons with onchocerciasis but without epilepsy The type of virusses present in the O. volvulus worm present in the nodules of persons with OAE and in nodules of persons without epilepsy 1 day
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