Intestinal DiseasesPhase 4NCT01192802
Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora
A Phase 4 study testing albendazole in people with Intestinal Diseases and Helminthiasis, run by Albert Schweitzer Hospital at 1 site in Gabon.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Diseases, Helminthiasis
- What is being tested?
- albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGabon
- Study dates
- Aug 2010to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- presence of intestinal helminths eggs in the stool
Who cannot join
- allergy to imidazole derivate
- No intestinal helminths
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Medical research Unit of Lambaréné
Lambaréné, Moyen-Ogooué Province, 118
About this study
Official title: 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.
- Conditions
- Intestinal Diseases, Helminthiasis
- Being tested
- albendazole
- Keywords
- albendazole, ascaris, trichiurus, hookworms
- Medical subject headings
- Intestinal Diseases, Helminthiasis, Hookworm Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albendazoleDrug
1 tablet of 400 mg of albendazole per day for three consecutive days
albendazoleDrug
single 1 tablet of 400 mg of albendazole
albendazoleDrug
1 tablet of 400 mg of albendazole per day for two consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 1 dose, Albendazole , tablet | Active comparator | Not described Receives: Drug: albendazole |
| 2 doses, albendazole, tablet | Active comparator | 1 tablet of 400 mg of albendazole per day for two consecutive days Receives: Drug: albendazole |
| 3 doses albendazole, 400mg, tablet | Active comparator | Not described Receives: Drug: albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
parasite cleared and reduced up to 80% at day 42
Measured: 42 days
Secondary outcomes (1)
Prevalence of major gut bacteria
Change in the prevalence of major gut bacteria after antihelminth treatment.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Schweitzer Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192802
- Sponsor's protocol ID
- Albendazole-001
- Status last verified
- Jan 2013
- First submitted
- 31 Aug 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24550339
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intestinal Helminths on Gut Microflora
- ClinicalTrials.gov ID
- NCT01192802
- Acronym / sponsor ID
- Albendazole-001
- Conditions
- Intestinal Diseases, Helminthiasis
- Keywords
- albendazole, ascaris, trichiurus, hookworms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Albert Schweitzer HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 dose, Albendazole , tablet | Active comparator | Drug: albendazole |
| 2 doses, albendazole, tablet | Active comparator | Drug: albendazole1 tablet of 400 mg of albendazole per day for two consecutive days |
| 3 doses albendazole, 400mg, tablet | Active comparator | Drug: albendazole |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- presence of intestinal helminths eggs in the stool
Key exclusion criteria (2 listed)
- allergy to imidazole derivate
- No intestinal helminths
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albendazole1 tablet of 400 mg of albendazole per day for three consecutive days | Drug | 3 doses albendazole, 400mg, tablet |
| albendazolesingle 1 tablet of 400 mg of albendazole | Drug | 1 dose, Albendazole , tablet |
| albendazole1 tablet of 400 mg of albendazole per day for two consecutive days | Drug | 2 doses, albendazole, tablet |
Primary outcome
parasite cleared and reduced up to 80% at day 42
Time frame: 42 days
1 secondary outcome
Prevalence of major gut bacteria
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- Derived from this study: PubMed 24550339Adegnika 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.
- Medical Research Unit of the Albert Schweitzer HospitalLink provided by the sponsor.
Related trials for Intestinal Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing albendazole in people with Intestinal Diseases and Helminthiasis, run by Albert Schweitzer Hospital at 1 site in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parasite cleared and reduced up to 80% at day 42 (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.