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NCT01192802 Clinical Trial

Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora

Intestinal Diseases Clinical Trial

Official title:
Effect of Intestinal Helminths on Gut Microflora

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01192802
Other study ID # Albendazole-001
Secondary ID
Status Completed
Phase Phase 4
First received August 31, 2010
Last updated January 23, 2013
Start date August 2010
Est. completion date July 2012

Study information
Verified date January 2013
Source Albert Schweitzer Hospital
Contact n/a
Is FDA regulated No
Health authority Lambarene: Albert Schweitzer Hospital
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 14 Years
Eligibility Inclusion Criteria:

- presence of intestinal helminths eggs in the stool

Exclusion Criteria:

- allergy to imidazole derivate

- No intestinal helminths

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• albendazole
1 tablet of 400 mg of albendazole per day for three consecutive days
• albendazole
single 1 tablet of 400 mg of albendazole
• albendazole
1 tablet of 400 mg of albendazole per day for two consecutive days

Locations
Country Name City State
Gabon Medical research Unit of Lambaréné Lambarene Moyen ogooue

Sponsors (1)
Lead Sponsor Collaborator
Albert Schweitzer Hospital

Country where clinical trial is conducted

Gabon, 

Outcome
Type Measure Description Time frame Safety issue
Primary parasite cleared and reduced up to 80% at day 42 42 days No
Secondary Prevalence of major gut bacteria Change in the prevalence of major gut bacteria after antihelminth treatment. 42 days No
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