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

January 23, 2013 updated by: Albert Schweitzer Hospital

Effect of Intestinal Helminths on Gut Microflora

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
    • Moyen ogooue
      • Lambarene, Moyen ogooue, Gabon, 118
        • Medical research Unit of Lambaréné

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of intestinal helminths eggs in the stool

Exclusion Criteria:

  • allergy to imidazole derivate
  • No intestinal helminths

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
parasite cleared and reduced up to 80% at day 42
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of major gut bacteria
Time Frame: 42 days
Change in the prevalence of major gut bacteria after antihelminth treatment.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Schweitzer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (Estimate)

September 1, 2010

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Albendazole-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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