Effect of repeated three-monthly albendazole treatments on malaria and allergic disease

ISRCTN	ISRCTN83830814
DOI	https://doi.org/10.1186/ISRCTN83830814
Protocol serial number	05-PP-35
Sponsor	Royal Netherlands Academy of Arts and Sciences (Netherlands)
Funder	Royal Netherlands Academy of Arts and Sciences (Netherlands) (ref: 05-PP-35)

Submission date: 08/12/2008
Registration date: 27/02/2009
Last edited: 02/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Maria Yazdanbakhsh
Scientific

Department of Parasitology
Leiden University Medical Centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Email	M.Yazdanbakhsh@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Parasitic infections and Inflammatory Diseases: The web of immune responses, host genetics and environmental exposure
Study objectives	Intestinal helminth infections suppress atopy and incidence of malaria and this suppression is reversible by antihelminthic treatment
Ethics approval(s)	University of Indonesia, approved on 11/09/2006 (ref: 194/ PT02.FK/Etik/2006)
Health condition(s) or problem(s) studied	Helminth and malaria parasitic diseases
Intervention	400 mg albendazole (oral) or matching placebo every three months for 2 years.
Intervention type	Other
Primary outcome measure(s)	1. Prevalence of malaria parasite, assessed throughout the study for 3 years 2. Infection with intestinal helminth before treatment and within 1, 2 and 3 years after start of treatment 3. Skin reactivity to allergens assessed before treatment and within 1, 2 and 3 years after start of treatment
Key secondary outcome measure(s)	Immune response to malaria and helminth antigens, assessed before albendazole treatment and within 1, 2 and 3 years after the start of treatment (with the last treatment given at least 2 months before immunological determination).
Completion date	01/11/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	4000
Total final enrolment	4004
Key inclusion criteria	1. Both males and females 2. Age >=2 years. No upper age limit. 3. Those who have given informed consent
Key exclusion criteria	1. History of chronic liver, heart or central nervous system (CNS) disease 2. Allergy to albendazole
Date of first enrolment	01/11/2008
Date of final enrolment	01/11/2011

Locations

Countries of recruitment

Indonesia
Netherlands

Study participating centre

Department of Parasitology

Leiden
2333 ZA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013		Yes	No
Results article	results	09/08/2018		Yes	No
Results article	gut microbiome results	06/11/2019	02/12/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

02/12/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the 2013 reference.
10/08/2018: Publication reference added.