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

Phase 4

Completed

• Conditions: Intestinal Diseases; Helminthiasis
• Interventions: Drug: albendazole

• Registration Number: NCT01192802
• Lead Sponsor: Albert Schweitzer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-08-31
• Study First Posted: 2010-09-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• presence of intestinal helminths eggs in the stool

Exclusion Criteria

• allergy to imidazole derivate
• No intestinal helminths

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3 doses albendazole, 400mg, tablet	albendazole	-
1 dose, Albendazole , tablet	albendazole	-
2 doses, albendazole, tablet	albendazole	1 tablet of 400 mg of albendazole per day for two consecutive days

Primary Outcome Measures

Name	Time	Method
parasite cleared and reduced up to 80% at day 42	42 days

Secondary Outcome Measures

Name	Time	Method
Prevalence of major gut bacteria	42 days	Change in the prevalence of major gut bacteria after antihelminth treatment.

Trial Locations

Locations (1)

Medical research Unit of Lambaréné; 🇬🇦 Lambarene, Moyen ogooue, Gabon