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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192802
First Posted: September 1, 2010
Last Update Posted: January 24, 2013
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.
Information provided by:
Albert Schweitzer Hospital
  Purpose
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 Intervention Phase
Intestinal Diseases Helminthiasis Drug: albendazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intestinal Helminths on Gut Microflora

Resource links provided by NLM:


Further study details as provided by Albert Schweitzer Hospital:

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

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


Enrollment: 200
Study Start Date: August 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Ayola Akim ADEGNIKA, Medical Research Unit
ClinicalTrials.gov Identifier: NCT01192802     History of Changes
Other Study ID Numbers: Albendazole-001
First Submitted: August 31, 2010
First Posted: September 1, 2010
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Albert Schweitzer Hospital:
albendazole
ascaris
trichiurus
hookworms

Additional relevant MeSH terms:
Intestinal Diseases
Helminthiasis
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