Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora
Effect of Intestinal Helminths on Gut Microflora
1 other identifier
interventional
200
1 country
1
Brief Summary
Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy in the school children population. The aim of this study is to evaluate the efficacy of the albendazole one versus two and three doses, in school children infected with intestinal helminth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJanuary 24, 2013
January 1, 2013
1.9 years
August 31, 2010
January 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
parasite cleared and reduced up to 80% at day 42
42 days
Secondary Outcomes (1)
Prevalence of major gut bacteria
42 days
Study Arms (3)
1 dose, Albendazole , tablet
ACTIVE COMPARATOR2 doses, albendazole, tablet
ACTIVE COMPARATOR1 tablet of 400 mg of albendazole per day for two consecutive days
3 doses albendazole, 400mg, tablet
ACTIVE COMPARATORInterventions
1 tablet of 400 mg of albendazole per day for three consecutive days
Eligibility Criteria
You may qualify if:
- presence of intestinal helminths eggs in the stool
You may not qualify if:
- allergy to imidazole derivate
- No intestinal helminths
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical research Unit of Lambaréné
Lambaréné, Moyen-Ogooué Province, 118, Gabon
Related Publications (1)
Adegnika AA, Zinsou JF, Issifou S, Ateba-Ngoa U, Kassa RF, Feugap EN, Honkpehedji YJ, Dejon Agobe JC, Kenguele HM, Massinga-Loembe M, Agnandji ST, Mordmuller B, Ramharter M, Yazdanbakhsh M, Kremsner PG, Lell B. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection. Antimicrob Agents Chemother. 2014 May;58(5):2535-40. doi: 10.1128/AAC.01317-13. Epub 2014 Feb 18.
PMID: 24550339DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 1, 2010
Study Start
August 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
January 24, 2013
Record last verified: 2013-01