NCT01271049

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

January 3, 2011

Last Update Submit

December 11, 2012

Conditions

Helminthiasis

Outcome Measures

Primary Outcomes (1)

  • 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.

    43 days

Study Arms (2)

Control Food Product

PLACEBO COMPARATOR

Consumption of placebo food product

Other: Control Food Product

Novel Food Product

EXPERIMENTAL

Consumption of novel food product

Other: Novel Food Product

Interventions

Novel Food ProductOTHER

Novel food product containing essential oil blend

Novel Food Product
Control Food ProductOTHER

Control food product

Control Food Product

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Male or Female adults, age 18-45 years old inclusive on date of screening
  • Showing presence of no or mild-moderate helminths

You may not qualify if:

  • Presence of heavy helminth load
  • Pregnant or lactating
  • Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Pesquisas Rene Rachou-FIOCRUZ

Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Helminthiasis

Condition Hierarchy (Ancestors)

Parasitic DiseasesInfections

Study Officials

  • David Diemert, MD, FRCP(C)

    Rene Rachou Research Center, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 6, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

BR(1)