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

• Sponsor: Albert Schweitzer Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01192802
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 3
• Duration (Months): 23
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Diseases; Helminthiasis	Drug: albendazole; Drug: albendazole; Drug: albendazole	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Intestinal Helminths on Gut Microflora
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 dose, Albendazole , tablet	Drug: albendazole; single 1 tablet of 400 mg of albendazole
Active Comparator: 2 doses, albendazole, tablet 1 tablet of 400 mg of albendazole per day for two consecutive days	Drug: albendazole; 1 tablet of 400 mg of albendazole per day for two consecutive days
Active Comparator: 3 doses albendazole, 400mg, tablet	Drug: albendazole; 1 tablet of 400 mg of albendazole per day for three consecutive days

Outcome Measures

Primary Outcome Measures

1. parasite cleared and reduced up to 80% at day 42 [42 days]

Secondary Outcome Measures

1. Prevalence of major gut bacteria [42 days]

   Change in the prevalence of major gut bacteria after antihelminth treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• presence of intestinal helminths eggs in the stool

Exclusion Criteria:

• allergy to imidazole derivate

• No intestinal helminths

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical research Unit of Lambaréné	Lambarene	Moyen ogooue	Gabon	118

Sponsors and Collaborators

• Albert Schweitzer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Medical Research Unit of the Albert Schweitzer Hospital

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01192802
• Other Study ID Numbers: Albendazole-001
• First Posted: Sep 1, 2010
• Last Update Posted: Jan 24, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by , ,: albendazole; ascaris; trichiurus; hookworms
• Additional relevant MeSH terms: Helminthiasis; Intestinal Diseases; Albendazole

Study Results

No Results Posted as of Jan 24, 2013