Back to resultsEfficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora
Primary Purpose
Intestinal Diseases, Helminthiasis
Status
Completed
Phase
Phase 4
Locations
Gabon
Study Type
Interventional
Intervention
albendazole
albendazole
albendazole
Sponsored by
About this trial
This is an interventional treatment trial for Intestinal Diseases focused on measuring albendazole, ascaris, trichiurus, hookworms
Eligibility Criteria
Inclusion Criteria:
- presence of intestinal helminths eggs in the stool
Exclusion Criteria:
- allergy to imidazole derivate
- No intestinal helminths
Sites / Locations
- Medical research Unit of Lambaréné
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1 dose, Albendazole , tablet
2 doses, albendazole, tablet
3 doses albendazole, 400mg, tablet
Arm Description
1 tablet of 400 mg of albendazole per day for two consecutive days
Outcomes
Primary Outcome Measures
parasite cleared and reduced up to 80% at day 42
Secondary Outcome Measures
Prevalence of major gut bacteria
Change in the prevalence of major gut bacteria after antihelminth treatment.
Full Information
NCT ID
NCT01192802
First Posted
August 31, 2010
Last Updated
January 23, 2013
Sponsor
Albert Schweitzer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01192802
Brief Title
Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora
Official Title
Effect of Intestinal Helminths on Gut Microflora
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Albert Schweitzer Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Diseases, Helminthiasis
Keywords
albendazole, ascaris, trichiurus, hookworms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 dose, Albendazole , tablet
Arm Type
Active Comparator
Arm Title
2 doses, albendazole, tablet
Arm Type
Active Comparator
Arm Description
1 tablet of 400 mg of albendazole per day for two consecutive days
Arm Title
3 doses albendazole, 400mg, tablet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
albendazole
Intervention Description
1 tablet of 400 mg of albendazole per day for three consecutive days
Intervention Type
Drug
Intervention Name(s)
albendazole
Intervention Description
single 1 tablet of 400 mg of albendazole
Intervention Type
Drug
Intervention Name(s)
albendazole
Intervention Description
1 tablet of 400 mg of albendazole per day for two consecutive days
Primary Outcome Measure Information:
Title
parasite cleared and reduced up to 80% at day 42
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Prevalence of major gut bacteria
Description
Change in the prevalence of major gut bacteria after antihelminth treatment.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
presence of intestinal helminths eggs in the stool
Exclusion Criteria:
allergy to imidazole derivate
No intestinal helminths
Facility Information:
Facility Name
Medical research Unit of Lambaréné
City
Lambarene
State/Province
Moyen ogooue
ZIP/Postal Code
118
Country
Gabon
12. IPD Sharing Statement
Citations:
PubMed Identifier
24550339
Citation
Adegnika AA, Zinsou JF, Issifou S, Ateba-Ngoa U, Kassa RF, Feugap EN, Honkpehedji YJ, Dejon Agobe JC, Kenguele HM, Massinga-Loembe M, Agnandji ST, Mordmuller B, Ramharter M, Yazdanbakhsh M, Kremsner PG, Lell B. Randomized, controlled, assessor-blind clinical trial to assess the efficacy of single- versus repeated-dose albendazole to treat ascaris lumbricoides, trichuris trichiura, and hookworm infection. Antimicrob Agents Chemother. 2014 May;58(5):2535-40. doi: 10.1128/AAC.01317-13. Epub 2014 Feb 18.
Results Reference
derived
Links:
URL
http://www.lambarene.org
Description
Medical Research Unit of the Albert Schweitzer Hospital
Learn more about this trial
Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora
We'll reach out to this number within 24 hrs