Effectiveness of treatment with clioquinol on parasitologic eradication is being studied as well as the clinical effectiveness of eradication in children with dientamoeba fragilis infection.
ID
Source
Brief title
Condition
- Gastrointestinal signs and symptoms
- Protozoal infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in symptoms in children with dientamoeba fragilis after treatment with
clioquinol and placebo.
Parasitological eradication
Secondary outcome
In de gebruikte duur en dosering van behandeling worden zelden bijwerkingen
gezien. In zeer hoge dosering kan het middel neurotoxisch zijn.
Background summary
Dientamoeba fragilis infection is associated with gastrointestinal symptoms in
a lot of children. Few studies evaluating tratment of D. fragilis infection in
children are available. Drugs that have been used are: iodoquinol, paromomycine
(Humatin), metronidazol en tetracycline. In the USA the first choice for
therapy is iodoquinol and second choice is paromomycin. Because iodoquinol is
not available in the Netherlands, clioquinol is currently used for treatment of
D. fragilis. In children treated in the Academic medical Centrum (AMC) in
Amsterdam, clioquinol proved to be effective for eradication of the parasite
and dissapearance of symptoms. Studies towards effectiveness of clioquinol in
children with D. fragilis have, as far as we know, not been described.
Study objective
Effectiveness of treatment with clioquinol on parasitologic eradication is
being studied as well as the clinical effectiveness of eradication in children
with dientamoeba fragilis infection.
Study design
The effectiveness of clioquinol will be evaluated in a cross-over treatment.
One part of the population will be treated with paromomycin 15 mg/kg/day during
7 days, the other part with placebomedication. After 14 days the group that
received clioquinol will now receive placebo and vice versa. A diary is being
held starting 4 days before treatment untill 3 weeks after start of treatment.
With this diary changing of symptoms can be studied optimally. 3 weeks after te
start of treatment a TFT-test is being done followed by parasitologic
evaluation. The primary endpoint is clinical effectiveness, the secondary
endpoint parasitological effectiveness.
Study burden and risks
As found in literature clioquinol in normal doses has limited side-effects.
Only in very high doses neurotoxicity has been reported.
oosterpark 9
1090 HM Amsterdam
Nederland
oosterpark 9
1090 HM Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
infection with dientamoeba fragilis
age between 4 and 18 years old
Exclusion criteria
co-infection with a pathogen
IBD (colitis Ulcerosa)
Oncologic patients
immune compromised patients
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14810.067.06 |