HelminthiasisNCT01271049
An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths
A study testing Novel Food Product in people with Helminthiasis, run by Mondelēz International, Inc. at 1 site in Brazil.
Trial summary
The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Helminthiasis
- What is being tested?
- Novel Food Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Feb 2012
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male or Female adults, age 18-45 years old inclusive on date of screening
- Showing presence of no or mild-moderate helminths
Who cannot join
- Presence of heavy helminth load
- Pregnant or lactating
- Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Controlled Evaluation of the Tolerability of a Proprietary Oil Blend in Adults Residing in Areas Endemic for Helminth Infections.
The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.
- Conditions
- Helminthiasis
- Being tested
- Novel Food Product, Control Food Product
- Medical subject headings
- Helminthiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Food ProductOther
Novel food product containing essential oil blend
Control Food ProductOther
Control food product
| Study group | Role | What they receive |
|---|---|---|
| Control Food Product | Placebo comparator | Consumption of placebo food product Receives: Other: Control Food Product |
| Novel Food Product | Experimental | Consumption of novel food product Receives: Other: Novel Food Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Safety and Tolerability using the Reactogenicity Questionairre
Reactogenicity will be assessed using a structured questionnaire on days 2, 14, 28, and 42 of the study. In addition, blood will be collected on study days 14 and 42 for assessment of basic hematologic and clinical chemistry parameters.
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Due to a business decision to stop the project, the study was terminated early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HelminthiasisStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TyraTech Technology
- Responsible party
- Sponsor
- Investigators
- David Diemert, MD, FRCP(C), Principal investigator, Rene Rachou Research Center, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271049
- Sponsor's protocol ID
- ABS-00-02
- Status last verified
- Dec 2012
- First submitted
- 3 Jan 2011
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled Evaluation of the Tolerability of a Proprietary Oil Blend in Adults Residing in Areas Endemic for Helminth Infections.
- ClinicalTrials.gov ID
- NCT01271049
- Acronym / sponsor ID
- ABS-00-02
- Conditions
- Helminthiasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a business decision to stop the project, the study was terminated early.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- TyraTech Technology
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Jan 2011 (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.
The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Food Product | Placebo comparator | Other: Control Food ProductConsumption of placebo food product |
| Novel Food Product | Experimental | Other: Novel Food ProductConsumption of novel food product |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Male or Female adults, age 18-45 years old inclusive on date of screening
- Showing presence of no or mild-moderate helminths
Key exclusion criteria (3 listed)
- Presence of heavy helminth load
- Pregnant or lactating
- Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine
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 |
|---|---|---|
| Novel Food ProductNovel food product containing essential oil blend | Other | Novel Food Product |
| Control Food ProductControl food product | Other | Control Food Product |
Primary outcome
Measure of Safety and Tolerability using the Reactogenicity Questionairre
Time frame: 43 days
Reactogenicity will be assessed using a structured questionnaire on days 2, 14, 28, and 42 of the study. In addition, blood will be collected on study days 14 and 42 for assessment of basic hematologic and clinical chemistry parameters.
Results and safety
The study was stopped early (reason given: Due to a business decision to stop the project, the study was terminated early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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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.
David Diemert, MD, FRCP(C) principal investigator
Rene Rachou Research Center, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Food Product in people with Helminthiasis, run by Mondelēz International, Inc. at 1 site in Brazil.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Dec 2012. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to a business decision to stop the project, the study was terminated early.). Results are not available in the source record.
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?
Measure of Safety and Tolerability using the Reactogenicity Questionairre (time frame: 43 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2012.