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

This study has been completed.
Sponsor:
Information provided by:
Albert Schweitzer Hospital
ClinicalTrials.gov Identifier:
NCT01192802
First received: August 31, 2010
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intestinal Helminths on Gut Microflora

Resource links provided by NLM:

Drug Information available for: Albendazole
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of major gut bacteria [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192802

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

Additional Information:
Medical Research Unit of the Albert Schweitzer Hospital  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Ayola Akim ADEGNIKA, Medical Research Unit
ClinicalTrials.gov Identifier: NCT01192802     History of Changes
Other Study ID Numbers: Albendazole-001
Study First Received: August 31, 2010
Last Updated: January 23, 2013
Health Authority: Lambarene: Albert Schweitzer Hospital

Keywords provided by Albert Schweitzer Hospital:
albendazole
ascaris
trichiurus
hookworms

Additional relevant MeSH terms:
Helminthiasis
Intestinal Diseases
Parasitic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Albendazole
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013