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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01192802
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : January 24, 2013
Sponsor:
Information provided by:
Albert Schweitzer Hospital

Study Description
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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 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : August 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Arms and Interventions
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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
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Primary Outcome Measures :
  1. parasite cleared and reduced up to 80% at day 42 [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. Prevalence of major gut bacteria [ Time Frame: 42 days ]
    Change in the prevalence of major gut bacteria after antihelminth treatment.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • presence of intestinal helminths eggs in the stool

Exclusion Criteria:

  • allergy to imidazole derivate
  • No intestinal helminths
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192802


Locations
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Gabon
Medical research Unit of Lambaréné
Lambarene, Moyen ogooue, Gabon, 118
Sponsors and Collaborators
Albert Schweitzer Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Ayola Akim ADEGNIKA, Medical Research Unit
ClinicalTrials.gov Identifier: NCT01192802    
Other Study ID Numbers: Albendazole-001
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013
Keywords provided by Albert Schweitzer Hospital:
albendazole
ascaris
trichiurus
hookworms
Additional relevant MeSH terms:
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Helminthiasis
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Parasitic Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
 Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents