An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths

Not Applicable

Terminated

• Conditions: Helminthiasis
• Interventions: Other: Control Food Product; Other: Novel Food Product

• Registration Number: NCT01271049
• Lead Sponsor: Mondelēz International, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-06
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Food Product	Control Food Product	Consumption of placebo food product
Novel Food Product	Novel Food Product	Consumption of novel food product

Primary Outcome Measures

Name	Time	Method
Measure of Safety and Tolerability using the Reactogenicity Questionairre	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.

Trial Locations

Locations (1)

Centro de Pesquisas Rene Rachou-FIOCRUZ; 🇧🇷 Minas Gerais, Brazil